Published on 5 December 2023

ADHD

• Guanfacine ^G

ALL

• ARI-0001

• Brexucabtagene autoleucel

  • Tecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).
• Crisantaspase
• Obecabtagene autoleucel

• Ponatinib

  • Extension of indication to include treatment of newly diagnosed adult patients with Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL), either with Iclusig (ponatinib) in combination with chemotherapy, or with Iclusig (ponatinib) monotherapy after corticosteroid induction in patients not eligible to receive chemotherapybased regimens.

ALS

• Masitinib

  • Amyotrophic lateral sclerosis (ALS), add on in patients on a stable dose of riluzole.
• Sodium phenylbutyrate / ursodoxicoltaurine
• Tofersen

AML / MDS

• Decitabine / cedazuridine

  • Inaqovi is indicated as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy

• Gilteritinib

  • A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML).
• Imetelstat
• Iomab-B

• Ivosidenib

  • Tibsovo in combinatie met azacitidine is geïndiceerd voor de behandeling van volwassen patiënten met nieuw gediagnosticeerde acute myeloïde leukemie (AML) met een R132-mutatie in isocitraatdehydrogenase-1 (IDH1), die niet in aanmerking komen voor standaard inductiechemotherapie.

• Luspatercept

  • Extension of indication to include treatment of adult patients with anaemia due to very low, low and intermediate -risk myelodysplastic syndromes (MDS), who may require RBC transfusions for Reblozyl.
• Magrolimab

• Quizartinib

  • Vanflyta is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive.

Aggressive non-Hodgkin’s lymphoma

• Acalabrutinib

  • Mantle cell lymphoma (MCL), 1L.

• Axicabtagene ciloleucel

  • Yescarta is indicated for the treatment of adult patients with diffuse large B‑cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.

• Brentuximab vedotin

  • Extension of indication to include in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) treatment of adult patients with previously untreated CD30+ peripheral T-cell lymphoma not otherwise specified (PTCL-NOS).

• Epcoritamab

  • Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

• Glofitamab

  • Columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B‑cell lymphoma (DLBCL), after two or more lines of systemic therapy.

• Ibrutinib

  • Imbruvica in combination with R-CHOP or R-DHAP for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are eligible for autologous stem cell transplantation (ASCT).

• Lisocabtagene maraleucel

  • Breyanzi is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

• Loncastuximab tesirine

  • Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.
• Odronextamab ^IND

• Pirtobrutinib

  • Jaypirca as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have been previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor.

• Polatuzumab vedotin

  • Polivy in combinatie met rituximab, cyclofosfamide, doxorubicine en prednison (R-CHP) is geïndiceerd voor de behandeling van volwassen patiënten met niet eerder behandeld diffuus grootcellig B-cellymfoom (DLBCL).

• Tafasitamab

  • MINJUVI is indicated in combination with lenalidomide followed by MINJUVI monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT)

Antithrombotic medications

• Dabigatran ^G
• Tenecteplase ^IND

Asthma

• Tezepelumab

  • Add-on treatment in adult and adolescent patients with severe asthma

Bacterial infections

• Aztreonam / avibactam
• Bezlotoxumab
• Ceftobiprole
• Citric acid / lactic acid / potassium bitartrate ^IND
• Clindamycin

• Dalbavancine

  • Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA
• Durlobactam / sulbactam
• Faecal microbiota transplant
• Gepotidacin
• Oritavancin diphosphate ^IND
• Ridinilazole

Bladder cancer

• Durvalumab

  • Neo-adjuvant durvalumab met chemotherapie en adjuvant durvalumab voor behandeling in patiënten met spier invasieve blaaskanker.

• Enfortumab vedotin

  • Enfortumab Vedotin and Pembrolizumab in Untreated Locally Advanced or Metastatic Urothelial Cancer

• Erdafitinib

  • Erdafitinib voor de behandeling van volwassen patiënten met een lokaalgevorderd, niet-resecteerbaar of gemetastaseerd urotheelcelcarcinoom met specifieke genetische afwijkingen in FGFR3 en ziekteprogressie tijdens of na tenminste 1 PD-(L)1 remmer-bevattende behandellijn.
• Inbakicept

• Nivolumab

  • Extension of indication to include in combination with cisplatin-based chemotherapy the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.

Bowel diseases

• Budesonide

  • Proctitis Ulcerosa (mild matig)

• Etrasimod

  • Treatment of patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological agent

• Filgotinib

  • Crohn disease (bowel disease) Moderately to Severe
• Glepaglutide

• Guselkumab

  • Tremfya is geïndiceerd voor de behandeling van volwassen patiënten met matig tot ernstige colitis ulcerosa die onvoldoende hebben gereageerd op, niet meer reageren op of intolerant waren voor conventionele behandeling of een biologische behandeling.
  • Tremfya is geïndiceerd voor de behandeling van volwassen patiënten met matig tot ernstig actieve ziekte van Crohn die onvoldoende hebben gereageerd op, niet meer reageren op of intolerant waren voor conventionele behandeling of een biologische behandeling.

• Mirikizumab

  • Omvoh is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment
• Obefazimod ^IND

• Risankizumab

  • Skyrizi is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment

• Teduglutide

  • Revestive is indicated for the treatment of patients 4 months corrected gestational age 1 year and above with Short Bowel Syndrome (SBS). Patients should be stable folllowing a period of intestinal adaptation after surgery.

• Upadacitinib

  • RINVOQ is geïndiceerd voor de behandeling van volwassen patiënten met matige tot ernstige actieve ziekte van Crohn die onvoldoende reageerden op, niet meer reageerden op of intolerant waren voor een conventionele behandeling of een biologisch geneesmiddel (‘biological’).

• Ustekinumab

  • Moderately to severely active Ulcerative Colitis

Brain cancer

• Dabrafenib / trametinib

  • Finlee in combination with trametinib is indicated for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. Finlee in combination with trametinib is indicated for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment.

Breast cancer

• Atezolizumab

  • Atezolizumab plus chemotherapy for patients with early relapsing recurrent triple-negative breast cancer

• Capivasertib

  • Locally advanced (inoperable) or metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) breast cancer following recurrence or progression on or after endocrine therapy.

• Datopotamab deruxtecan

  • Datopotamab deruxtecan as monotherapy is indicated for the treatment of adult patients with locally recurrent inoperable or metastatic Triple-Negative Breast Cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
  • Datopotamab deruxtecan as monotherapy is indicated for the treatment of adult patients with inoperable or metastatic HR-Positive, HER2-negative Breast Cancer who have been treated with one or two prior lines of systemic chemotherapy.
• Elacestrant

• Paclitaxel

  • Histologically- or cytologically-confirmed breast cancer that is metastatic for whom treatment with IV paclitaxel monotherapy has been recommended by their oncologist.

• Palbociclib

  • Treatment for patients diagnosed with HR+/HER2+ metastatic breast cancer.

• Ribociclib

  • Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/​HER2- Early Breast Cancer
  • Extension of indication to include the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, Stage II or Stage III early breast cancer, irrespective of nodal status, in combination with an AI for Kisqali.

• Sacituzumab govitecan

  • Trodelvy is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting

• Trastuzumab deruxtecan

  • Extension of indication to include treatment of HER2-low/ultra-low hormone receptor positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.
  • Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2‑low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy
  • Extension of indication for Enhertu to include treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.
  • Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti HER2 based regimens.
• Trastuzumab duocarmazine

CLL

• Acalabrutinib

  • Extension of the existing CLL indication to include combination treatment with venetoclax for previously untreated patients.
  • Calquence as monotherapy is indicated for the treatment of adult patients with relapsed/refractory CLL (chronic lymphocytic leukemia).

• Pirtobrutinib

  • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL)

• Zanubrutinib

  • Extension of indication to include treatment of adult patients with chronic lymphocytic leukaemia (CLL).
  • Extension of indication to include treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one-prior anti-CD20-based therapy

COPD

• Dupilumab

  • For the treatment of adults as add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) with type 2 inflammation on triple therapy or double therapy if inhaled corticosteroids (ICS) are contraindicated.
• Ensifentrine

COVID-19

• Casirivimab / imdevimab

  • Extension of indication to include treatment of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40kg and receiving supplemental oxygen, who have a negative SARS-CoV-2 antibody test result.
• Molnupiravir
• Sabizabulin
• Vilobelimab ^IND

Cervical cancer

• Cadonilimab

• Dostarlimab

  • Extension of indication to include in combination with carboplatin and paclitaxel for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability high (MSI H) primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy

Colon cancer

• Eflornithine / sulindac
• Fruquintinib
• Pembrolizumab / favezelimab

• Trifluridine / tipiracil

  • Lonsurf is geïndiceerd in combinatie met bevacizumab voor de behandeling van volwassen patiënten met gemetastaseerd colorectaal carcinoom (CRC) die eerder twee kankerbehandelschema’s hebben gekregen, waaronder chemotherapie op basis van fluorpyrimidine, oxaliplatine en irinotecan, antiVEGF-middelen en/of anti-EFGR-middelen.

Cystic fibrosis

• Lumacaftor / ivacaftor

  • Extension of indication to include treatment of cystic fibrosis for children aged 1 to less than 2 years old of age who are homozygous for the F508del mutation in the CFTR gene.

Dementia

• Blarcamesine
• Donanemab
• Hydromethylthionine mesylaat
• Lecanemab

Depression

• Agomelatine ^IND

Diabetes

• Dasiglucagon

  • For the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus type 1.
• Deudomperidone
• Dulaglutide ^IND

• Empagliflozine

  • Extension of indication for Jardiance to include treatment of children aged 10 years and above with type 2 diabetes.

• Finerenon

  • Extension of indication to include the treatment of chronic kidney disease (CKD) and for the prevention of cardiovascular (CV) events in adults with CKD (regardless of the stage of albuminuria) associated with type 2 diabetes
• Insulin Icodec
• Regulatoire T-cellen (TREGS)
• Teplizumab

Duchenne

• Delandistrogene moxeparvovec
• Fordadistrogene movaparvovec

• Givinostat

  • Ambulant Patients With Duchenne Muscular Dystrophy
• Losmapimod

• Vamorolone

  • Agamree is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and older
• Viltolarsen

Epilepsy

• Fenfluramine

  • Extension of indication to include treatment of seizures associated with Lennox-Gastaut syndrome as an add on therapy to other anti-epileptic medicines for patients 2 years of age and older.
• Ganaxolone

Eye disorders

• Aflibercept

  • Diabetic macular edema
• Avacincaptad pegol
• Bevacizumab-vikg
• Bimatoprost
• Botaretigene sparoparvovec
• Brimonidine tartrate/carbachol

• Ciclosporine

  • Treatment of Signs and Symptoms of Dry Eye Disease

• Faricimab

  • Bloedvat afsluiting in netvlies (BRVO/CRVO)
• Laruparetigene zosaparvovec

• Pegcetacoplan

  • Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
• Phentolamine
• Polihexanide

• Reproxalap

  • Moderate to severe dry eye disease
• Varenicline

Fungal infections

• Oteseconazole
• Rezafungin

HIV

• Semzuvolimab

Head and neck cancer

• Atezolizumab

  • Adjuvant therapy after definitive local therapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck.

• Leukocyte interleukin

  • Cancer of the oral cavity, neoadjuvant

• Tislelizumab

  • 1L recurrent/metastatic nasopharyngeal cancer (NPC).
• Xevinapant

Headache

• Atogepant

  • Aquipta is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.
• Dihydroergotamine

Hemostasis promoting medication

• Emicizumab

  • Hemlibra is indicated for Routine prophylaxis of bleeding episodes in patients with haemophilia A without factor VIII inhibitors who have moderate disease with severe bleeding phenotype.
• Etranacogene dezaparvovec
• Fidanacogene elaparvovec
• Nonacog beta pegol ^IND
• Peboctocogene camaparvovec
• Valoctocogene roxaparvovec

• Vonicog alfa

  • Extension of indication for the prevention and treatment of haemorrhage or surgical bleeding in adults (age 18 years and older) with von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or contraindicated.

Hodgkin's lymphoma

• Brentuximab vedotin

  • ADCETRIS is indicated for adult patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD).

Indolent non-Hodgkin’s lymphoma

• Axicabtagene ciloleucel

  • Yescarta is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.

• Epcoritamab

  • Third line follicular lymphoma

• Tafasitamab

  • MINJUVI is indicated in relapsed/ refractory follicular and marginal zone lymphoma in combination with rituximab and lenalidomide.

• Zanubrutinib

  • Brukinsa in combination with obinutuzumab is indicated for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.

Infectious diseases other

• Baloxavir marboxil

  • Extension of indication for the treatment of uncomplicated influenza and post-exposure prophylaxis of influenza in patients aged 1 years and above.
• Cefepime / Enmetazobactam
• Cefepime/taniborbactam
• Fluticasone propionate

Kidney cancer

• Atezolizumab

  • In combination with cabozantinib in patients with advanced renal cell carcinoma after immune checkpoint inhibitor treatment
• Ilixadencel

Lipid-lowering medications

• Alirocumab

  • Extension of indication to include treatment of paediatric patients 8 years of age and older with heterozygous familial hypercholesterolemia (HeFH) as an adjunct to diet, alone or in combination with other LDL -C lowering therapies.
• Bempedoic acid

• Evinacumab

  • Extension of indication to include the treatment of paediatric patients with homozygous familial hypercholesterolaemia (HoFH) aged 5 years and older

Liver cancer

• Atezolizumab

  • Extension of indication to include, in combination with bevacizumab, adjuvant treatment of adult patients with hepatocellular carcinoma at high risk of recurrence after surgical resection or ablation.

• Durvalumab

  • Imfinzi as monotherapy is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).
  • Durvalumab (+/- bevacizumab) in combinatie met TACE in patiënten met locoregionale HCC.

• Tremelimumab

  • Imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).

Liver diseases

• Arachidyl amido cholanoic acid
• Elafibranor

• Maralixibat

  • Treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older.
  • Treatment of cholestasis in Progressive Familial Intrahepatic Cholestasis.

• Obeticholic acid

  • Fibrosis due to Non-Alcoholic Steatohepatitis (NASH)

• Odevixibat

  • Extension of indication to include treatment of cholestasis and pruritus in Alagille syndrome (ALGS) in patients from birth and older for BYLVAY.
• Resmetirom

Lung cancer

• Adagrasib

• Alectinib

  • The adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA ALK-positive NSCLC

• Amivantamab

  • Amivantamab in combination with chemotherapy is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations.
  • Amivantamab in combination with lazertinib is indicated for the treatment of adult patients with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon 19del] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).
  • Amivantamab in combination with chemotherapy is indicated for the treatment of adult patients with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon 19del] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) after osimertinib failure.

• Atezolizumab

  • Neoadjuvant atezolizumab with chemotherapy in patients with resectable stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC).
  • Atezolizumab subcutaneous in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC).
• Aumolertinib (mesilate)

• Cemiplimab

  • LIBTAYO in combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with NSCLC expressing PD-L1 (in ≥ 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC.

• Datopotamab deruxtecan

  • Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer, who have received at least one systemic therapy

• Domvanalimab

  • first-line treatment of patients with metastatic non-small cell lung cancer with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations

• Durvalumab

  • Imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations.
  • Limited stage small cell lung cancer (LS-SCLC) following concurrent platinum-based chemotherapy and radiation therapy in combination with Tremelimumab.
  • Lokaal gevorderd, niet-resectabel NSCLC (stadium III)

• Ipilimumab

  • Extension of indication to include in combination with nivolumab the treatment of adult patients with unresectable stage III NSCLC
• Lazertinib

• Nintedanib

  • Treatment of non-small cell lung cancer (NSCLC)

• Nivolumab

  • OPDIVO in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥1%

• Osimertinib

  • Stage III unresectable Epidermal Growth Factor Receptor (EGFR) mutation positive non-small cell lung cancer (NSCLC)
  • Osimertinib in combination with pemetrexed and platinum based chemotherapy for locally advanced (clinical stage IIIB, IIIC) or metastatic Non-Small Cell Lung Cancer (NSCLC) (clinical stage IVA or IVB) or recurrent Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
• Pembroliuzmab ^IND

• Pembrolizumab

  • Extension of indication to include in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant, treatment of resectable stage II, IIIA, or IIIB (T3 4N2) non-small cell lung carcinoma in adults.
  • KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum‑based chemotherapy.

• Selpercatinib

  • Retsevmo as monotherapy is indicated for the treatment of adults with advanced RET fusion positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.

• Serplulimab

  • Treatment of extensive-stage small cell lung cancer (ES-SCLC)

• Sugemalimab

  • First-line treatment-naive subjects with stage IV non-small cell lung cancer (NSCLC) in combination with platinum-containing chemotherapy.

• Tislelizumab

  • 1L squamous NSCLC (combi): In combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of locally advanced or metastatic squamous NSCLC in adults
  • 2L NSCLC (mono): As monotherapy for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy in adults
  • 1L non-squamous NSCLC (combi): In combination with pemetrexed and platinum-containing chemotherapy for the first-line treatment of locally advanced or metastatic non-squamous NSCLC in adults whose tumors have no EGFR or ALK positive mutations

• Toripalimab

  • Patients with advanced non-small cell lung cancer without activated EGFR mutation (exon 19 deletion, or exon 21 L858R, exon 21 L861Q, exon 18 G719X or exon 20 S768I mutations) and ALK fusion in combiantion With Chemotherapy.

• Trastuzumab deruxtecan

  • Enhertu as monotherapy is indicated for the treatment of adult patients with advanced NSCLC whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

• Tremelimumab

  • Tremelimumab AstraZeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.

Lung diseases other

• Gefapixant

• Nintedanib

  • Treatment of chronic fibrosing interstitial lung diseases in paediatric patients from 6 to 17 years.
• Pamrevlumab

• Pirfenidone

  • Extension of indication to include treatment of ‘advanced’ idiopathic pulmonary fibrosis (IPF) by the deletion of the current qualifier ‘mild to moderate’, in IPF patients with advanced lung function impairment (DLco < 40% of predicted) and at high risk of grade 3 pulmonary hypertension.

• Riociguat

  • Adempas is indicated for the treatment of PAH in paediatric patients aged less than 18 years of age and body weight ≥ 50 kg with WHO Functional Class (FC) II to III in combination with endothelin receptor antagonists.

• Sotatercept

  • Treatment of Pulmonary Arterial Hypertension
• Tadalafil ^IND
• Zinpentraxin alfa

Metabolic diseases

• ALXN1840

• Afamelanotide

  • Extension of indication for the prevention of phototoxicity in adolescent patients (12 to under 18 years of age) with erythropoietic protoporphyria (EPP).
• Avalglucosidase alfa
• Cipaglucosidase alfa

• Empagliflozine

  • Jardiance is indicated in adults for the treatment of chronic kidney disease.
• Encaleret
• Fezolinetant
• Leriglitazone
• Nedosiran
• Olenasufligene relduparvovec
• Palopegteriparatide
• Palovarotene
• Pegunigalsidase alfa
• RGX-121
• Sepiapterin

• Somapacitan

  • Sogroya is indicated for the replacement of endogenous growth hormone (GH) in children aged 3 years and above and adolescents with growth failure due to growth hormone deficiency (paediatric GHD), and in adults with growth hormone deficiency (adult GHD)

• Somatrogon

  • Ngenla is geïndiceerd voor de behandeling van kinderen en adolescenten vanaf 3 jaar met een groeistoornis als gevolg van onvoldoende secretie van groeihormoon.

• Sparsentan

  • IgA-nefropathie (ook wel: ziekte van Berger) Focal Segmental Glomerulosclerosis (nog geen registratie traject aangevraagd)

Multiple Myeloma

• Ciltacabtagene autoleucel

  • Extension of indication to include treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 1 prior therapy, including an IMiD and a PI, have demonstrated disease progression on or after the last therapy and are refractory to lenalidomide

• Daratumumab

  • Multipel myeloom frontline behandeling in combinatie met VRd voor patiënten die in aanmerking komen voor een ASCT.

• Elranatamab

  • Elrexfio is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

• Idecabtagene vicleucel

  • Extension of indication to include treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD-38 antibody and have demonstrated disease progression on the last therapy.

• Isatuximab

  • In Combination With Bortezomib, Lenalidomide and Dexamethasone (Isa VRd) in Patients With Newly Diagnosed Multiple Myeloma (NDMM) Not Eligible for Transplant.

• Melphalan flufenamide

  • Pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior lines of therapies, whose disease is refractory to lenalidomide and the last line of therapy.

• Pomalidomide

  • Treatment of adult patients with relapsed and refractory multiple myeloma in combination with dexamethasone

• Selinexor

  • In combinatie met bortezomib en dexamethason voor de behandeling van volwassen patiënten met multipel myeloom die ten minste één eerdere therapie hebben ondergaan.

• Talquetamab

  • Talquetamab is geïndiceerd als monotherapie voor de behandeling van volwassen patiënten met recidiverend en refractair multipel myeloom die minimaal 3 eerdere behandelingen hebben gekregen, waaronder een immunomodulerend middel, een proteasoomremmer en een antiCD38antilichaam en die tijdens de laatste therapie ziekteprogressie hebben vertoond.

• Teclistamab

  • Tecvayli is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

• Venetoclax

  • Patients With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma
• Zevorcabtagene autoleucel

Multiple sclerosis

• Natalizumab

  • actieve relapsing-remitting multiple sclerose (zie indicatie huidige spécialité).
• Ponesimod

• Ublituximab

  • Briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features

Muscular diseases other

• Dantroleen ^G
• Daxibotulinumtoxine A
• Deoxythymidine / deoxycytidine
• Di-deuterated ethyl linoleate

• Eculizumab

  • Extension of indication to include treatment of paediatric patients aged 6 years and above with acetylcholine receptor-antibody (AChR-Ab) positive (+) refractory gMG.

• Efgartigimod

  • Vyvgart is geïndiceerd als een aanvulling op de standaardtherapie voor de behandeling van volwassen patiënten met gegeneraliseerde myasthenia gravis (gMG) die positief testen op antilichamen tegen acetylcholinereceptoren (AChR).
• Omaveloxolone
• Rozanolixizumab

• Satralizumab

  • Generalized Myasthenia
• Zilucoplan

Myeloproliferative disorders

• Avapritinib

  • Advanced systemic mastocytosis (AdvSM). AYVAKYT is indicated as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated haematological neoplasm (SM-AHN) or mast cell leukaemia (MCL), after at least one systemic therapy.
• Momelotinib
• Navitoclax
• Pelabresib

• Pemigatinib

  • Myeloid/Lymphoid Neoplasms ((8p11 var)

Neurological disorders other

• Cannabidiol

  • Children and Adolescents With Fragile X Syndrome aged 3 to < 18 years.
• Clazosentan

• Human normal immunoglobulin

  • Extension of indication to include treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in adults.

• Ravulizumab

  • Ultomiris is indicated in the treatment of adult patients with NMOSD who are anti-aquaporin 4 (AQP4) antibody-positive

• Satralizumab

  • Patiënten met neuromyelitis optica‑spectrumstoornissen (NMOSD), die seropositief zijn voor anti-aquaporine-4-IgG (AQP4-IgG) (vanaf 12 jaar).

• Tiratricol

  • Treatment of monocarboxylate transporter 8 (MCT8) deficiency
• Trofinetide
• Troriluzole

Oncology other

• AL102
• Afamitresgene autoleucel

• Durvalumab

  • Imfinzi in combination with gemcitabine and cisplatin is indicated for the first‑line treatment of adults with unresectable or metastatic biliary tract cancer (BTC).
• Efbemalenograstim alfa

• Entrectinib

  • Two pediatric indications: 1) Rozlytrek as monotherapy for the treatment of paediatric patients with solid tumours that have a ROS1 gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior ROS1 inhibitor, and who have no satisfactory treatment options. 2) indication extension to pediatric patients <12 years with solid tumours that have a NTRK gene fusion who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor, and who have no satisfactory treatment options.
• Futibatinib

• Ivosidenib

  • Monotherapie met Tibsovo is geïndiceerd voor de behandeling van volwassen patiënten met lokaal gevorderd of gemetastaseerd cholangiocarcinoom met een R132-mutatie in IDH1 die eerder zijn behandeld met minstens één eerdere lijn van systemische therapie.
• Melphalan hydrochloride
• Nirogacestat

• Nivolumab

  • Extension of indication to include in combination with fluoropyrimidineand platinum-based combination chemotherapy the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) for OPDIVO.

• Pembrolizumab

  • Indication for treatment in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults.

• Retifanlimab

  • Monotherapy for the treatment of adult patients with Merkel Cell Carcinoma with distant metastatic disease or recurrent advanced locoregional disease not amenable to surgery or radiation

• Selinexor

  • Patients diagnosed with advanced unresectable dedifferentiated liposarcoma.
• Sodium thiosulfate

• Tebentafusp

  • Kimmtrak is geïndiceerd als monotherapie voor de behandeling van humaan leukocytenantigeen (HLA)-A*02:01-positieve volwassen patiënten met een niet-resectabel of gemetastaseerd uveamelanoom.

• Tislelizumab

  • 1L locally advanced or metastatic ESCC (esophageal squamous-cell carcinoma)
  • Tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy.

• Toripalimab

  • Toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (“ESCC”)
  • Toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma (“NPC”)

Other chronic immune diseases

• Arachis hypogaea (pinda) allergenen ^IND

• Avapritinib

  • Extension of indication to include treatment of adult patients with indolent systemic mastocytosis (ISM) with moderate to severe symptoms inadequately controlled on symptomatic treatment.

• Budesonide

  • Extension of indication to slow kidney function decline in adults with primary immunoglobulin A (IgA) nephropathy (IgAN).
• Coacillium topical
• FCR 001

• Lanadelumab

  • TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 2 years and older.

• Leniolisib

  • Treatment for activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency, in adolescents and adults 12 years or older.
• Lorecivivint
• Marnetegragene autotemcel

• Ritlecitinib

  • Litfulo is geïndiceerd voor de behandeling van ernstige alopecia areata bij volwassenen en adolescenten van 12 jaar en ouder

• Sarilumab

  • Volwassen patienten met polymyalgia rheumatica (PMR)
• Sebetralstat
• Sizavaleucel

• Tocilizumab

  • Extension of indication to include treatment of new indication for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) for RoActemra.
• Voclosporin

Other hematology

• Lenzilumab

• Obinutuzumab

  • Extension of indication to include the pre-treatment to reduce the risk of cytokine release syndrome (CRS) induced by glofitamab for Gazyvaro.

Other medication for cardiovascular diseases

• Aficamten

• Bempedoic acid / ezetimibe

  • Extension of indication to include treatment of adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk.

• Dapagliflozine

  • dapagliflozin is indicated in adults for the treatment of symptomatic chronic heart failure
• Etripamil
• Macitentan / tadalafil

• Marstacimab

  • Indicated for routine prophylaxis of bleeding episodes in patients with haemophilia A or haemophilia B.

• Mavacamten

  • Camzyos is indicated for the treatment of symptomatic (New York Heart Association, NYHA, class II III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients.
• Neoatricon (dopamine)
• Omecamtiv mecarbil
• Rexlemestrocel-L

• Sotagliflozine

  • Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure

• Valsartan / sacubitril

  • Extension of indication to include treatment of children and adolescents aged one year or older with chronic heart failure with left ventricular systolic dysfunction.

• Vericiguat

  • Verquvo is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilised after a recent decompensation event requiring IV therapy

Other metabolism and Endocrinology

• Abaloparatide

  • Treatment of osteoporosis in postmenopausal women at increased risk of fracture

• Alpelisib

  • PIK3CA-Related Overgrowth Spectrum (PROS). PROS omvat de onderstaande syndromen: - Goedaardige lichenoïde keratose (BLK) - Dysplastische megalencefalie (DMEG) - CLOVES (aangeboren lipomateuze overgroei, vasculaire malformatie, epidermal naevi-syndroom) - Epidermal naevi (EN) - Fibro-adipeuze overgroei (FAO) - Hemimegalencefalie (HMEG) - Hemihyperplasie - meervoudige lipomatose (HHML) geïsoleerde grote lymfatische malformatie (ILM) - Megaencefalie- capillaire malformatie (MCAP) - Muscular hemihyperplasia (mHH) - Seborrhoïsche keratose (SK)
• C-type natriuretic peptide prodrug
• Copper histidine

• Linzagolix

  • Moderate to Severe Endometriosis Associated Pain

• Pegzilarginase

  • Loargys is indicated for the treatment of arginase 1 deficiency (ARG1‑D), also known as hyperargininemia, in adults, adolescents and children aged 2 years and older.

• Semaglutide

  • Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with obesity and body weight above 60 kg. Treatment with Wegovy should be discontinued and re-evaluated if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on the 2.4 mg or maximum tolerated dose.
  • Extension of indication to include risk reduction of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and BMI ≥27 kg/m2.

• Tirzepatide

  • Uitbreiding van de indicatie: voor gewichtsbeheersing bij volwassenen met obesitas of overgewicht met gewichtsgerelateerde comorbide aandoeningen.

• Vosoritide

  • Voxzogo is indicated for the treatment of achondroplasia in patients 4 months of age and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

Other non-oncological hematological medications

• Apadamtase alfa ^IND
• Aprocitentan

• Concizumab

  • Hemofilie A met inhibitors en hemofilie B met inhibitors, met een leeftijd van 12 jaar en ouder.
  • Hemofilie A en B zonder inhibitors en een leeftijd van 12 jaar en ouder.
• Crizanlizumab
• Crovalimab
• Danicopan
• Daprodustat
• Efanesoctocog alfa

• Efgartigimod

  • Idiopathic thrombocytopenic purpura (ITP)
• Exagamglogene autotemcel

• Hydroxycarbamide

  • Extension of indication to include the prevention of vaso-occlusive complications of sickle cell disease in children from 6 months to 2 years of age.

• Iptacopan

  • Treatment of adult patients with paroxysmal nocturnal haemoglobinuria.

• Luspatercept

  • Reblozyl is indicated in adults for the treatment of anaemia associated with transfusion-dependent and non-transfusion-dependent beta-thalassaemia Extension of indication in β-thalassaemia to include adult patients with non-transfusion dependent β-thalassaemia (NTDT).
• Methoxy polyethylene glycol-epoetin beta ^IND
• Mim 8
• Mozafancogene autotemcel

• Pegcetacoplan

  • Extension of indication to include treatment of adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously treated with a complement inhibitor
• Pozelimab

• UM171

  • Patients With Sickle-Cell Disease
• Vadadustat

Ovarian cancer

• Dostarlimab

  • Stage III or IV non mucinous epithelial ovarian, fallopian tube, or peritoneal cancer (collectively referred to as "ovarian cancer")
• Mirvetuximab soravtansine

• Rucaparib

  • Extension of indication as monotherapy for the maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

Pain

• Difluprednate

Pancreatic cancer

• Gemcitabine
• Irinotecan in gepegyleerde liposomen ^IND

Parasitic infections

• Lotilaner

Prostate cancer

• Atezolizumab

  • In combination with cabozantinib patients with mCRPC previously treated with novel hormonal therapy (NHT)

• Darolutamide

  • Nubeqa is indicated for the treatment of adult men with metastatic hormone‑sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy .

• Degarelix

  • Degarelix Accord is a gonadotrophin releasing hormone (GnRH) antagonist indicated for treatment of adult male patients with advanced hormone-dependent prostate cancer, for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy and as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

• Enzalutamide

  • Extension of indication to include treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy.
• Gozetotide

• Lutetium (177lu) vipivotide tetraxetan

  • Pluvicto in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane based chemotherapy.

• Niraparib

  • Niraparib in combination with abiraterone acetate and prednisone for treatment of patients with metastatic prostate cancer

• Niraparib / abirateron

  • Akeega is indicated with prednisone or prednisolone for the treatment of adult patients with metastatic castration resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.

• Olaparib

  • Treatment in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated.

• Rucaparib

  • Treatment of metastatic castration resistant prostate cancer (CRPC) associated with a deleterious alteration in either the BRCA1, BRCA2 or ATM genes.

• Talazoparib

  • Talzenna is indicated in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.

Rheumatism

• Baricitinib

  • Extension of indication to include treatment, as monotherapy or in combination with conventional synthetic disease modifying antirheumatic drugs (DMARDs), of active juvenile idiopathic arthritis (JIA) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic DMARDs.

• Bimekizumab

  • Bimzelx is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs), and for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.
  • Bimzelx, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
• Cyclobenzaprine hydrochloride
• Dapansutrile

• Sarilumab

  • Patients aged 2-17 years with Polyarticular Juvenile Idiopathic Arthritis (pJIA)

SMA

• Apitegromab

• Risdiplam

  • Extension of indication to include treatment of patients below 2 months of age.

Schizophrenia, psychosis, bipolar disorder

• Roluperidon

Skin cancer

• Daromun

• Ipilimumab

  • Extension of indication to include in combination with nivolumab the treatment of adolescents (12 years of age and older) for advanced (unresectable or metastatic) melanoma.
  • Neoadjuvant Ipilimumab Plus Nivolumab in Macroscopic Stage III Melanoma.

• Nivolumab

  • Extension of indication to include adolescent patients aged 12 years and older in treatment of advanced (unresectable or metastatic) melanoma (nivolumab monotherapy), treatment of advanced (unresectable or metastatic) melanoma (nivolumab in combination with ipilimumab) and adjuvant treatment of melanoma (nivolumab monotherapy).
  • Extension of indication to include OPDIVO for the adjuvant treatment of adults and adolescents 12 years of age and older with stage IIB or IIC melanoma who have undergone complete resection.
• Tavokinogene telseplasmid

Skin diseases

• Abrocitinib

  • Extension of indication to include treatment of adolescents 12 to < 18 years of age with moderate to severe atopic dermatitis
  • Behandeling van matige tot ernstige constutioneel eczeem in adolsecenten

• Baricitinib

  • Baricitinib is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years and older who are candidates for systemic therapy.
• Beremagene geperpavec ^IND

• Bimekizumab

  • Extension of indication to include treatment of moderate to severe hidradenitis suppurativa (HS) in adults
• Clascoterone
• Concentrate of proteolytic enzymes enriched in bromelain ^IND
• Dabocemagene autoficel
• Delgocitinib

• Deucravacitinib

  • Sotyktu is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

• Dupilumab

  • Extension of indication to include treatment of severe atopic dermatitis in paediatric patients from 6 months to <6 years of age.
• EB101

• Lebrikizumab

  • Ebglyss is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy.
• Methotrexaat ^IND
• Nemolizumab
• Piclidenoson
• Remibrutinib

• Roflumilast topicaal

  • Chronic plaque psoriasis

• Ruxolitinib phosphate

  • Opzelura is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
  • Matig tot milde atopische dermatitis.

• Secukinumab

  • Extension of indication to include treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy

• Sirolimus

  • Hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older.

• Spesolimab

  • Spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis (GPP) as monotherapy.
  • Spevigo is indicated for the prevention of flares in adult patients with generalised pustular psoriasis (GPP) as monotherapy.

Sleep disorders

• Pitolisant

  • Extension of indication to include treatment of narcolepsy with or without cataplexy in adolescents and children from the age of 6 years.

Stem cell transplants

• Abatacept

  • Extension of indication to include the prophylaxis of acute Graft versus Host Disease (aGvHD) in the adult and paediatric population for Orencia.
• ECT-001-CB
• Narsoplimab
• Nomacopan
• Tabelecleucel

• Treosulfan

  • Treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients, and in paediatric patients older than one month with malignant and non‑malignant diseases.

Stomach cancer

• Catumaxomab

• Domvanalimab

  • previously untreated locally advanced unresectable or metastatic gastric, gastroesophageal junction, and esophageal adenocarcinoma

• Pembrolizumab

  • Treatment in the neoadjuvant or adjuvant setting of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
  • Extension of indication to include in combination with fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1.
  • Extension of indication for treatment with pembrolizumab plus trastuzumab in combination with standard of care chemotherapy for adults with HER2 positive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

• Tislelizumab

  • 1L locally advanced or metastatic gastric carcinoma

• Trastuzumab deruxtecan

  • Enhertu as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
• Zolbetuximab

Thyroid cancer

• Selpercatinib

  • Retsevmo is als monotherapie geïndiceerd voor de behandeling van volwassenen en adolescenten van 12 jaar en ouder met gevorderd RET-gemuteerd medullair schildkliercarcinoom (MTC).
  • Extension of indication to include the treatment of adults and adolescents 12 years and older with advanced RET-fusion-positive thyroid cancer in the first line setting.

Tumour agnostic medication

• Selpercatinib

  • Extension of indication for Retsevmo to include the treatment of adults with advanced or metastatic RET fusion-positive solid tumours with disease progression on or after prior systemic therapies or who have no satisfactory therapeutic options.

Unknown

• ARINA-1

• Apremilast

  • Treatment of psoriatic arthritis, psoriasis, Behçet’s disease
• Binimetinib/encorafenib ^IND
• Eplontersen

• Isatuximab

  • In combination with bortezomib, lenalidomide and dexamethasone (Isa VRd) in patients with newly diagnosed multiple myeloma (NDMM) eligible for transplant.
• Mirabegron ^IND
• Molgramostim ^IND

• Olaparib

  • Extension of indication for Lynparza in combination with Imfinzi for the maintenance treatment of adult patients with newly diagnosed advanced or recurrent endometrial cancer following treatment with Imfinzi and platinum-based chemotherapy.

• Pembrolizumab

  • Extension of indication to include in combination with chemoradiotherapy (external beam radiation therapy followed by brachytherapy) the treatment of high-risk locally advanced cervical cancer in adults who have not received prior definitive therapy.
• Relugolix / estradiol / norethisterone acetaat ^IND
• Vibegron

Viral infections other

• Bizalimogene ralaplasmid
• Dolutegravir/ abacavir /lamivudine ^IND

• Letermovir

  • Extension of indication to include treatment of prophylaxis of CMV disease in CMV-seronegative adults who have received a kidney transplant from a CMV-seropositive donor [D+/R-].
  • Extension of Letermovir From Day 100 to Day 200 Post-transplant for the Prevention of Cytomegalovirus Infection in Hematopoietic Stem Cell Transplant.
• Maribavir

• Nirsevimab

  • Extension of indication to include treatment of children up to 24 months of age who remain vulnerable to severe Respiratory Syncytial Virus (RSV) disease through their second RSV season.
• Posoleucel
• Tenofovir alafenamide ^IND