Oncology

Bladder cancer

• Cretostimogene grenadenorepvec
• Detalimogene voraplasmid
• Disitamab Vedotin

• Durvalumab

  • Extension of indication for IMFINZI in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adults with BCG-naive, high-risk non-muscle-invasive bladder cancer (NMIBC).
  • Durvalumab in combination with enfortumab vedotin for neoadjuvant and durvalumab monotherapy for adjuvant treatment of muscle-invasive urothelial carcinoma bladder in adults and elderly who are cisplatin-ineligible or refused cisplatin and are undergoing radical cystectomy (VOLGA).
  • Unresectable locally advanced or metastatic urothelial cancer in combination with tremelimumab and chemotherapy.
  • Imfinzi in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC).

• Enfortumab vedotin

  • Enfortumab vedotin in combination with pembrolizumab indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults who are eligible for platinum-containing chemotherapy.
  • Padcev, in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with resectable muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy
• Mitomycine (UGN-103)
• Mitomycine extended release
• Nadofaragene firadenovec

• 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.

• Nogapendekin alfa inbakicept

  • Anktiva in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.
  • Nogapendekin alfa inbakicept in combination with bacillus calmette-guerin for second line treatment of BCG-unresponsive, high-grade Ta/T1 disease non-muscle invasive bladder cancer in adults and elderly.
• Paclitaxel/hyaluronzuur

• Padeliporfin

  • Padeliporfin monotherapy for first line treatment of low grade non-invasive Renal pelvis and ureter transitional cell cancer localized in adults and elderly.

• Pembrolizumab

  • Pembrolizumab in combination with gemcitabine and cisplatin followed by surgery and postoperative pembrolizumab for neoadjuvant treatment of non-metastatic muscle invasive Bladder cancer in adults and elderly who are eligible for radical cystectomy and pelvic lymph node dissection.
  • Pembrolizumab in combination with Bacillus Calmette-Guerin for adjuvant treatment of high risk non-muscle invasive bladder cancer in adults and elderly who have undergone cystoscopy/TURBT and are BCG-naive.
  • Keytruda, in combination with chemoradiotherapy, is indicated for the treatment of adults with muscle-invasive bladder cancer (MIBC) who choose bladder preservation.
  • Extension of indication to include KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adults with muscle invasive bladder cancer (MIBC) who are eligible for cisplatin containing chemotherapy.
• Sasanlimab
• TAR-200

Brain cancer

• Berubicin
• Dordaviprone
• Idroxioleenzuur
• Naxitamab

• Tovorafenib

  • Ojemda is indicated as monotherapy for the treatment of patients 6 months of age and older with paediatric low‑grade glioma (LGG) harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies.
  • Tovorafenib monotherapy for first line treatment of patients 6 months of age and olders with non-resectable or subtotally resected pediatric low grade glioma harbouring a BRAF fusion or rearrangement or BRAF V600 mutation. Indicatiestelling is inschatting obv lopende fase III studie FIREFLY 2/LOGGIC:
• Vorasidenib

Breast cancer

• Alpelisib

  • Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/​6 Inhibitor and an Aromatase Inhibitor.

• Camizestrant

  • Etcamah in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) is indicated for the treatment of adult patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1‑mutation and without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor
  • Camizestrant in combination with palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease.

• Capivasertib

  • Truqap is indicated in combination with fulvestrant for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2‑negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen.

• Datopotamab deruxtecan

  • Extension of indication to include, as monotherapy, the first-line treatment of adult patients with unresectable 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 Datroway as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting.
• Eftilagimod alfa
• GLSI-100

• Gedatolisib

  • Gedatolisib in combination with palbociclib and fulvestrant for second line or later treatment of advanced or metastatic PIK3CA mutated Hormone receptor positive HER2 negative breast cancer in adults and elderly previously treated with CDK4/6 and aromatase inhibitor therapy.

• Giredestrant

  • Giredestrant in combination with palbociclib for first line treatment of locally advanced or metastatic ER-positive HER2-negative breast cancer in adults and elderly.
  • Giredestrant in combinatie met everolimus voor de tweedelijnsbehandeling van lokaal gevorderde of gemetastaseerde, niet-reseceerbare, HR-positieve, HER2-negatieve borstkanker, na voorgaande behandeling met een CDK4/6-remmer plus endocriene therapie.
  • Giredestrant monotherapie als adjuvante behandeling van medium/high risk stadium I-III HR-positieve, HER2-negatieve borstkanker.
• Imlunestrant
• Inavolisib

• Olaparib

  • Monotherapie of in combinatie met endocriene therapie voor de adjuvante behandeling van volwassen patiënten met kiembaan-BRCA1/2-mutaties die HER2-negatieve, hoog-risico borstkanker in een vroeg stadium hebben en eerder behandeld zijn met neoadjuvante of adjuvante chemotherapie.

• Paclitaxel

  • Paclitaxel monotherapy for first line treatment of recurrent or metastatic HER2 negative breast cancer in adults over 19 years of age and elderly.
• Palazestrant

• Palbociclib

  • Treatment for patients diagnosed with HR+/HER2+ metastatic breast cancer.
  • Palbociclib Viatris is indicated for the treatment of hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative locally advanced or metastatic breast cancer. in combination with an aromatase inhibitor; in combination with fulvestrant in women who have received prior endocrine therapy (see section 5.1). In pre‑ or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone‑releasing hormone (LHRH) agonist.

• Pembrolizumab

  • Pembrolizumab in combination with neoadjuvant chemotherapy and adjuvant endocrine therapy for treatment of high risk early-stage, grade 3 ER-positive, HER2-negative Breast cancer in adults and elderly

• Pertuzumab

  • Indicated for use in combination with trastuzumab and chemotherapy in: • The neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence. • The adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence. It is also indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

• Ribociclib

  • 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 locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy
• Sacituzumab tirumotecan

• Trastuzumab deruxtecan

  • Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment.
  • 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.
  • Treatment of adult patients with HER2-positive breast cancer (IHC3+ or ISH+) who have residual invasive disease after neoadjuvant HER2 targeted treatment.
  • Extension of indication to include the indication first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer for Enhertu (trastuzumab deruxtecan) in combination with pertuzumab.

• Trastuzumab pamirtecan

  • Trastuzumab pamirtecan (Db-1303/bnt323) monotherapy for third line or later treatment of advanced or metastatic HER2-low, HR-positive Breast cancer in adults and elderly whose disease has progressed on endocrine therapy and/or cyclin-dependent kinase 4/6 (CDK4/6) therapy and who are chemotherapy-naïve.

• Tucatinib

  • In combination with trastuzumab and pertuzumab for the maintenance treatment of adult patients with unresectable locally advanced or metastatic HER2-positive breast cancer.
• Vepdegestrant

Cervical cancer

• Hexaminolevulinaathydrochloride
• Tisotumab vedotin

Colon cancer

• Atezolizumab

  • Tecentriq in combination with chemotherapy for the treatment of patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair
• Cetuximab ^IND

• Encorafenib

  • Encorafenib in combination with cetuximab and FOLFOX is indicated for the first line treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation

• Nivolumab

  • Extension of indication to include OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable or metastatic mismatch repair deficient or microsatellite instability-high colorectal cancer.

• Sotorasib

  • Sotorasib in combination with panitumumab for first-line treatment of KRAS p.G12C mutated metastatic colorectal cancer .

• Tucatinib

  • Treatment of patients with unresectable locally advanced or metastatic HER2 positive colorectal cancer.

• Zanzalintinib

  • Zanzalintinib in combination with atezolizumab for third line treatment of microsatellite stable or microsatellite instability low metastatic colorectal cancer in adults and elderly who have progressed after or are intolerant to standard-of-care therapy.

Head and neck cancer

• Pembrolizumab

  • Keytruda as monotherapy is indicated for the treatment of resectable locally advanced head and neck squamous cell carcinoma as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumours express PD-L1 with a CPS ≥ 1.

• Tislelizumab

  • Extension of indication to include, Tevimbra, in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of adult patients with recurrent, not amenable to curative surgery or radiotherapy, or metastatic nasopharyngeal carcinoma (NPC).

Kidney cancer

• Abexinostat

• Belzutifan

  • In combination with lenvatinib for treatment of advanced or metastatic clear cell renal cell carcinoma.
  • WELIREG is indicated as monotherapy for the treatment of adult patients with advanced clear cell renal cell carcinoma that progressed following two or more lines of therapy that included a PD-(L)1 inhibitor and at least two VEGF-targeted therapies.
  • Belzutifan in combination with lenvatinib for advanced renal cell carcinoma.
  • Belzutifan In combination with pembrolizumab, for the adjuvant treatment of adult patients with clear cell renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

• Pembrolizumab

  • Pembrolizumab plus lenvatinib with or without belzutifan or quavonlimab for advanced renal cell carcinoma.

• Zanzalintinib

  • Zanzalintinib in combination with nivolumab for first line treatment of unresectable, locally advanced or metastatic non-clear cell renal cell carcinoma in adults and elderly.

Liver cancer

• Atezolizumab

  • Atezolizumab in combination with lenvatinib for second line treatment of locally advanced or metastatic and/or unresectable hepatocellular carcinoma in adults and elderly who have progressed on prior systemic treatment with atezolizumab plus bevacizumab.
• Camrelizumab

• Durvalumab

  • IMFINZI in combinatie met tremelimumab is geïndiceerd voor de eerstelijnsbehandeling van volwassenen met gevorderd of irresectabel hepatocellulair carcinoom (HCC).
  • 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.
  • Durvalumab monotherapy for adjuvant treatment of newly diagnosed Hepatocellular carcinoma in adults and elderly who are at high risk of recurrence after curative hepatic resection or ablation
• Namodenoson

• Nivolumab

  • Extension of indication to include a new indication for OPDIVO in combination with ipilimumab as first line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC) based on study CA2099DW.
• Nofazinlimab
• Tinengotinib

• Tremelimumab

  • Tremelimumab (T) plus durvalumab (D) with or without lenvatinib combined with concurrent transarterial chemoembolisation (TACE) versus TACE alone in patients (pts) with locoregional hepatocellular carcinoma (HCC) (EMERALD-3).
  • Imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).

Lung cancer

• Amivantamab

  • 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).
  • In combination with carboplatin and pemetrexed for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor.
  • Amivantamab monotherapy for treatment of locally advanced or metastatic EGFR-mutated Non-small cell lung cancer in adults and elderly who are not amenable to curative therapy including surgical resection or chemoradiation.

• Atezolizumab

  • Neoadjuvant atezolizumab with chemotherapy in patients with resectable stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC).
• Aumolertinib (mesilate)
• Ceralasertib
• Cobolimab

• Datopotamab deruxtecan

  • Datopotamab deruxtecan with or without osimertinib is indicated for patients with advanced or metastatic EGFRm NSCLC whose disease has progressed on prior Osimertinib.

• Durvalumab

  • Limited stage small cell lung cancer (LS-SCLC) following concurrent platinum-based chemotherapy and radiation therapy in combination with Tremelimumab.
  • Imfinzi in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements.
  • A Phase III, Double-blind, Placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy. PACIFIC-9.
• Ensartinib
• Furmonertinib

• Ivonescimab

  • Ivonescimab in combination with pemetrexed and carboplatin for second line treatment of locally advanced or metastatic EGFR-mutant Non-squamous non-small cell lung cancer in adults and elderly who have progressed on or following EGFR-TKI treatment.
  • Ivonescimab in combination with chemotherapy for first line treatment of metastatic without actionable genomic mutations, squamous non-small cell lung cancer in adults and elderly.
• Lazertinib

• Lifileucel

  • Lifileucel monotherapy for second line or later treatment of metastatic stage iv non-ALK, non-EGFR, non-ROS mutated Non-small cell lung cancer in adults and elderly who have progressed on or after chemotherapy and anti-PD-1 therapy.

• Lurbinectedin

  • Zepzelca, in combination with atezolizumab, is indicated for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.
  • Lurbinectedin monotherapy for second line treatment of relapsed Small cell lung cancer in adults and elderly who failed one prior platinum-containing chemotherapy, with or without anti-PD-1 or anti-PD-L1 agents.
• Neladalkib
• Nibrozeton

• Nivolumab

  • Opdivo, in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria).

• Nogapendekin Alfa Inbakicept

  • Nogapendekin alfa inbakicept in combination with pembrolizumab, carboplatin and nab-paclitaxel for first line treatment of advanced or metastatic, stage 3 or 4 Non-small cell lung cancer in adults and elderly.
• Olomorasib

• Osimertinib

  • Extension of indication to include TAGRISSO in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
  • Neoadjuvant Osimertinib as Monotherapy or in Combination With Chemotherapy Versus Standard of Care Chemotherapy Alone for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer (NeoADAURA).
• Pegargiminase

• Pembrolizumab

  • Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first‑line treatment of adults with unresectable non-epithelioid malignant pleural mesothelioma.
  • Pembrolizumab in combination with sacituzumab govitecan for first line treatment of metastatic Non-small cell lung cancer in adults and elderly with PD-L1 proportion score greater than or equal to 50%.
  • Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC).
• Pembrolizumab / berahyaluronidase alfa ^IND
• Repotrectinib

• Savolitinib

  • Savolitinib in combination with osimertinib for second line or later treatment of locally advanced or metastatic epidermal growth factor receptor mutated, MET-overexpressed and/or amplified non-small cell lung cancer in adults and elderly who have progressed on treatment with osimertinib.

• Selpercatinib

  • Selpercatinib monotherapy for adjuvant treatment of early stage (IB-IIIA) RET fusion-positive Non-small cell lung cancer in adults and elderly following definitive locoregional treatment with curative intent.

• Serplulimab

  • Hetronifly in combination with carboplatin and nab-paclitaxel is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma
  • Serplulimab in combination with carboplatin-etoposide for first line treatment of small cell lung cancer extensive stage in adults and elderly.
  • Hetronifly in combination with carboplatin and pemetrexed is indicated for the first-line treatment of adult non-squamous NSCLC patients with no EGFR, ALK or ROS1 positive mutations and who have: locally advanced NSCLC who are not candidates for surgery or radiotherapy, or metastatic NSCLC
• Sigvotatug vedotin
• Sintilimab

• Sugemalimab

  • Cejemly in combination with 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, ROS1 or RET genomic tumour aberrations.
  • Cejemly as monotherapy is indicated for the treatment of unresectable stage III NSCLC with no sensitising EGFR mutations, or ALK, ROS1 genomic tumour aberrations in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiotherapy.
• Sunvozertinib
• Taletrectinib
• Tarlatamab

• Tislelizumab

  • Tizveni in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous non-small cell lung cancer who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC.
  • Locally advanced or metastatic (Stage IIIB or IV), NSCLC (squamous or non-squamous) who have disease progression during or after a platinum-containing regimen.
  • Tevimbra, in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of adult patients with resectable NSCLC at high risk of recurrence (for selection criteria, see section 5.1)
  • Tevimbra, in combination with etoposide and platinum chemotherapy, is indicated for the first-line treatment of adult patients with extensive-stage SCLC.

• 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.
  • first-line treatment in patients with unresectable, locally advanced, or metastatic non–small cell lung cancer (NSCLC) harboring HER2 exon 19 or 20 mutations (DL04).

• 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.
• Trilaciclib
• Zidesamtinib
• Zipalertinib
• Zopapogene imadenovec

Neuroendocrine cancer

• Cabozantinib

  • Cabometyx is indicated for the treatment of adult patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues.
• Lutetium (177Lu) edotreotide

• Lutetium (177Lu) oxodotreotide

  • Extension of indication to include the treatment of unresectable or metastatic, somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adolescents aged 12 years and older.

• Octreotide

  • Octreotide monotherapy for first line treatment of unresectable and/or metastatic, well-differentiated gastroenteropancreatic neuroendocrine tumour disease in adults and elderly.

Oncology other

• Afamitresgene autoleucel

• Belzutifan

  • WELIREG is indicated as monotherapy for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated, localised renal cell carcinoma (RCC), central nervous system (CNS) haemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable.

• Catequentinib

  • Treatment of synovial sarcoma or leiomyosarcoma.
• Catumaxomab
• Darovasertib

• Denosumab

  • Preventie van botcomplicaties (pathologische fractuur, bestraling van bot, ruggenmergcompressie of chirurgie van het bot) bij volwassenen met botmetastasen van solide tumoren. Behandeling van volwassenen en adolescenten met een volgroeid skelet met reusceltumor van het bot (‘giant cell tumour of bone’) die niet-reseceerbaar is of waarbij chirurgische resectie waarschijnlijk leidt tot ernstige morbiditeit.

• Dostarlimab

  • Dostarlimab in combination with carboplatin-paclitaxel followed by maintenance dostarlimab plus niraparib for treatment of recurrent or primary advanced Endometrial cancer in adults and elderly.
  • Dostarlimab monotherapy for first line treatment of stage ii/iii, locally advanced mismatch repair deficient (dMMR) / microsatellite instability-high (MSI-H) Rectal cancer in adults and elderly.

• Durvalumab

  • Durvalumab Given Concurrently With Definitive Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma  (KUNLUN).
• Letetresgene autoleucel

• Methotrexaat

  • Methotrexate monotherapy for induction, consolidation, maintenance treatment of primary vitreoretinal Lymphoma in adults over 21 years of age and elderly.
• Mirdametinib
• Nirogacestat
• OST31-164

• Olaparib

  • Extension of indication for Lynparza in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel.
• Ozekibart

• Pembrolizumab

  • Pembrolizumab in combination with definitive chemoradiotherapy for first line treatment of oesophageal carcinoma in adults and elderly who are ineligible for curative surgery.
  • Extension of indication to include, in combination with chemotherapy with or without radiation, the adjuvant treatment of mismatch repair deficient (dMMR) endometrial cancer in adults who are at high risk of recurrence.
• Pimicotinib

• Retifanlimab

  • Zynyz is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC).

• Selumetinib

  • Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adult patients with neurofibromatosis type 1 (NF1).
  • Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in patients with neurofibromatosis type 1 (NF1) aged 1 year to less than 7 years and for older patients with swallowing difficulties.

• Serplulimab

  • Hetronifly in combination with fluoropyrimidine- and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable, locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma whose tumours express PD-L1 with a CPS ≥ 5.

• Tebentafusp

  • Tebentafusp in combination with pembrolizumab for second line or later treatment of stage III or IV unresectable HLA-A*02:01 positive non-ocular Melanoma in adults and elderly who have progressed on an anti-PD1, received prior ipilimumab and, if applicable, received a BRAF kinase inhibitor.

• Toripalimab

  • Loqtorzi, in combination with cisplatin and paclitaxel, is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma.
  • Loqtorzi, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma.

• Trastuzumab

  • Extension application to introduce a new pharmaceutical form (solution for injection), a new strength (600 mg) and a new route of administration (subcutaneous use).

• Trastuzumab pamirtecan

  • Trastuzumab pamirtecan monotherapy for second line or later treatment of recurrent HER2-expressing endometrial cancer in adults and elderly previously treated with platinum-based therapy and ICI treatment.
• Vimseltinib

• Zanidatamab

  • Zanidatamab in combination with chemotherapy for first line treatment of unresectable locally advanced, recurrent or metastatic HER2-positive gastric, gastro-oesophageal junction and oesophageal adenocarcinoma in adults and elderly.
  • Ziihera as monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy (for biomarker-based patient selection, see section 4.2).

Ovarian cancer

• Azenosertib

• Dostarlimab

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

• Olaparib

  • In combination with durvalumab, paclitaxel/carboplatin (PC) and bevacizumab (bev), followed by maintenance durvalumab, bev, and olaparib in patients (pts) with newly diagnosed advanced ovarian cancer (AOC) without a tumor BRCA1/2 mutation (non-tBRCAm).
• Olvimulogene nanivacirepvec

• Pembrolizumab

  • Keytruda, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of platinum resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults whose tumours express PDL1 with a CPS ≥ 1 and who have received one or two prior systemic treatment regimens.

• Relacorilant

  • Treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
• Senaparib

Pancreatic cancer

• Glufosfamide
• Zenocutuzumab

• Zolbetuximab

  • Zolbetuximab in combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma.

Prostate cancer

• Aglatimagene besadenovec

• Apalutamide

  • Als neo-adjuvante en adjuvante behandeling in combinatie met ADT bij mannen met hoog-risico lokaal/lokaalgevorderde prostaatkanker die een radicale prostatectomie ondergaan.

• Capivasertib

  • Extension of indication to include include Truqap in combination with abiraterone for the treatment of metastatic castration-sensitive prostate cancer characterized by PTEN deficient tumours.

• Darolutamide

  • Extension of indication to include in combination with androgen deprivation therapy (ADT) the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC).

• Lutetium (177lu) vipivotide tetraxetan

  • Extension of indication to include treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after having progressed on androgen receptor pathway inhibitor (ARPI) and for whom chemotherapy is not yet clinically indicated.
• Mevrometostat
• Niraparib / abirateronacetaat ^IND
• Radium-223 ^IND

• Talazoparib

  • In combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.
  • In combinatie met enzalutamide voor de eerstelijnsbehandeling van patiënten met een gemetastaseerd, hormoonsensitief HRR+ prostaatcarcinoom.

Skin cancer

• Autologous Melanoma-derived Tumor Infiltrating Lymphocytes

• Cemiplimab

  • Libtayo as monotherapy is indicated for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation.

• Dabrafenib / trametinib

  • Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).

• Encorafenib

  • Encorafenib in combination with binimetinib and pembrolizumab for first line treatment of metastatic or unresectable locally advanced BRAF V600E/K mutation-positive cutaneous melanoma in adults and elderly.
• Fianlimab
• Imsamotide

• Ipilimumab

  • Neo-adjuvant (off-label) treatment with ipilimumab plus nivolumab followed by adjuvant treatment in high-risk patients only.
• Nemvaleukin alfa
• Nivolumab/relatlimab/hyaluronidase Ph20
• Patidegib

• Pembrolizumab

  • Keytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. Keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC or III melanoma and who have undergone complete resection.
• Tucidinostat

Stomach cancer

• Bezuclastinib

  • Tweedelijnsbehandeling van lokaal gevorderde, gemetastaseerde en/of niet-reseceerbare PDGFR-negatieve gastro-intestinale stromale tumor bij volwassenen en ouderen zonder succinaat dehydrogenasedeficiëntie en die eerder alleen met imatinib zijn behandeld, behandeling in combinatie met sunitinib.

• Durvalumab

  • Gastric or Gastro-oesophageal Junction Adenocarcinoma (GC/GEJC). Imfinzi in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant Imfinzi monotherapy, is indicated for the treatment of adults with resectable gastric or gastro‑oesophageal junction adenocarcinoma.

• Sugemalimab

  • Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma.

• Tislelizumab

  • Extension of indication to include in combination with platinum-based chemotherapy the first-line treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (OSCC).
  • Extension of indication to include in combination with platinum and fluoropyrimidine-based chemotherapy the first-line treatment of adult patients with human epidermal growth factor receptor-2 (HER-2)-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

• Trastuzumab deruxtecan

  • Trastuzumab deruxtecan (T-DXd) in patients with HER2-positive gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma who have progressed on or after a trastuzumab-containing regimen (DG04).
  • 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.

Thyroid cancer

• Dabrafenib / trametinib

  • Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2).

• Selpercatinib

  • Retsevmo as monotherapy is indicated for the treatment of paediatric patients 12 years of age and older with: advanced RET fusion-positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate); advanced RET-mutant medullary thyroid cancer (MTC); advanced RET fusion-positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted. For biomarker-based patient selection.

Tumour agnostic medication

• Trastuzumab deruxtecan

  • Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment and who have no satisfactory treatment options

Unknown

• Amisulpride ^G
• Emactuzumab
• Ivospemin

• Pembrolizumab

  • Pembrolizumab monotherapy in dMMR advanced or recurrent endometrial carcinoma.