Oncologie

Alvleesklierkanker

• Gemcitabine ^IND
• Glufosfamide
• Zenocutuzumab

Baarmoederhalskanker

• Hexaminolevulinate hydrochloride
• Tisotumab vedotin

Blaaskanker

• Cretostimogene grenadenorepvec
• Detalimogene voraplasmid

• 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).
  • 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.
• 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

  • Nogapendekin alfa in combination with bacillus calmette-guerin for third line treatment of BCG-unresponsive high-grade non-muscle invasive bladder cancer in adults and elderly with carcinoma in situ with or without papillary tumors.
• Paclitaxel/hyaluronic acid

• 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.
• Sasanlimab

Borstkanker

• Camizestrant

  • Camizestrant in combination with CDK4/6 inhibitors for add-on treatment of locoregionally recurrent or metastatic ER-positive, HER2-negative, ESR1-positive Breast cancer in adults and elderly.
  • 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

  • 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 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.
  • Datopotamab deruxtecan in combination with durvalumab is indicated for the treatment of stage I-III triple-negative breast cancer in patients who have residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.
• Db-1303/bnt323

• 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
• 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.

• 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 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.
  • For adult patients with unresectable or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for advanced disease
• Sv-br-1-gm

• 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.
  • Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DB05).
  • Trastuzumab deruxtecan (Enhertu) with or without pertuzumab compared to standard of care in patients with HER2-positive metastatic breast cancer (DB09).

• Tucatinib

  • Maintenance treatment of unresectable locally advanced or metastatic HER2 positive breast cancer.

Darmkanker

• Encorafenib

  • Encorafenib in combination with cetuximab and chemotherapy for first line treatment of stage IV metastatic BRAF V600E-mutant Colorectal cancer in adolescents over 16 years of age, adults and elderly.

• 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.

• 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.

Eierstokkanker

• Azenosertib

• Catequentinib

  • Catequentinib in combination with background chemotherapy for third line or later treatment of recurrent or metastatic cervical cancer, endometrial cancer, fallopian tube cancer, ovarian cancer, primary peritoneal carcinosarcoma in adults and elderly.

• 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

  • Extension of indication to include in combination with paclitaxel, with or without bevacizumab, the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 and who have received one or two prior systemic treatment regimens.
  • Pembrolizumab in combination with carboplatin/paclitaxel chemotherapy with or without bevacizumab followed by pembrolizumab+olaparib maintenance for first line treatment of stage III or IV BRCA non-mutated Fallopian tube cancer, Ovarian epithelial cancer, Primary peritoneal carcinosarcoma in adults and elderly.

• Relacorilant

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

Hersenkanker

• Berubicin
• Dordaviprone
• Eflornithine ^IND
• Naxitamab
• Temozolomide ^IND
• Tovorafenib
• Vorasidenib

Hoofd- en halskanker

• Buparlisib
• Cetuximab sarotalocan

• 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).

Huidkanker

• Cemiplimab

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

• Dabrafenib / trametinib

  • Extension of indication to include treatment of unresectable or metastatic melanoma with a BRAF V600 mutation and adjuvant treatment of Stage III melanoma with a BRAF V600 mutation for adolescents aged 12 years and older.
• Daromun

• 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.

• Lifileucel

  • Lifileucel in combination with pembrolizumab and follow-on IL-2 for first line or later treatment of metastatic stage IIIc, IIId, or IV unresectable melanoma in adults and elderly following lymphodepletion regimen.
  • Lifileucel in combination with follow-on IL-2 for second line treatment of stage IIIc/IV unresectable or metastatic Melanoma in adults and elderly.
• Nemvaleukin alfa
• Nivolumab/relatlimab/hyaluronidase Ph20
• Relatlimab / nivolumab
• Tucidinostat

Leverkanker

• 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.
• 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

• Pembrolizumab

  • Adjuvant pembrolizumab in patients with hepatocellular carcinoma (HCC) and complete radiologic response after surgical resection or local ablation.
• 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).

Longkanker

• Alectinib

  • Alecensa as monotherapy is indicated as adjuvant treatment following complete tumour resection for adult patients with ALK‑positive NSCLC at high risk of recurrence.

• 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).
  • Subcutaneous formulation of atezolizumab for treatment of PD-(L)-1 Cancer Immunotherapy in multiple tumor types.
  • Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with advanced NSCLC who are ineligible for platinum-based therapy.
• 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.

• 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

  • 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 (for selection criteria, see section 5.1).
  • 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.
  • Durvalumab With Stereotactic Body Radiation Therapy (SBRT) vs Placebo With SBRT in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients/​ Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation (PACIFIC-4).
• Ensartinib
• Furmonertinib

• Ivonescimab

  • First line treatment of stage IIIB / C or IV locally advanced or metastatic PD-L1-positive nonsmall cell lung cancer in adults and elderly with no EGFR-sensitive mutations or ALK gene translocations.
  • 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.
• Lazertinib

• Lurbinectedin

  • Small cell lung cancer (SCLC).
  • 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.

• 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).
• Patritumab deruxtecan
• 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 (MK-3475) Subcutaneous (SC) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC).
  • 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

• Retifanlimab

  • Lokaal gevorderd of gemetastaseerd stage IV niet-kleincellige longkanker eerste lijn.
• Savolitinib

• Serplulimab

  • Extension of indication to include 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.
  • Extension of indication to include HETRONIFLY in combination with carboplatin and pemetrexed is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung carcinoma who do not have EGFR or ALK positive mutations.
• Sigovatug vedotin

• 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

• Tiragolumab

  • In combination with atezolizumab for first line treatment of locally advanced, unresectable stage III Non-small cell lung cancer in adults and elderly who have no progression during or following concurrent platinum-based chemoradiotherapy.

• 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
• Zopapogene imadenovec

Maagkanker

• Bezuclastinib

• Durvalumab

  • Extension of indication for IMFINZI to include in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant IMFINZI monotherapy, for the treatment of adults with resectable gastric or gastro-oesophageal junction adenocarcinoma.
• Ripretinib

• 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.

Neuro-endocriene kanker

• 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.

Nierkanker

• Belzutifan

  • 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.
• Nivolumab/hyaluronidase Ph20 ^IND

• 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.

Oncologie, overig

• Acalabrutinib

  • diffuse large B-cell lymphoma (based on study ESCALADE- ACE-LY-312)); Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤75 Years With Previously Untreated Non-GCB DLBCL.
• 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

  • Extension of indication for JEMPERLI to include, in combination with carboplatin and paclitaxel, the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy.

• Durvalumab

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

• Entrectinib

  • Rozlytrek as monotherapy is indicated for the treatment of adult and pediatric patients older than 1 month with solid tumours that have a neurotrophic tyrosine receptor kinase (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 who have no satisfactory treatment option.
• 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.
• Onfekafusp Alfa
• 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.
• Pimicotinib

• Retifanlimab

  • Patiënten met inoperabele, lokaal gevorderd of gemetastaseerd plaveiselcarcinoom van het anale kanaal (squamous cell anal cancer (SCAC)), 1L (ODD) (+CT).

• Selinexor

  • Maintenance with selinexor after combination chemotherapy for patients with advanced or recurrent endometrial cancer.

• Selumetinib

  • Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adult patients with neurofibromatosis type 1 (NF1).

• Serplulimab

  • Extension of indication to include, in combination with fluoropyrimidine- and platinum-based chemotherapy, 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 ≥ 1

• 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 pamirtecan
• 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).

Prostaatkanker

• 177Lu-PNT2002

• 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 / abirateron

  • In combinatie met predniso(lo)n en ADT voor de behandeling van mannen met mHSPC en afwijkingen in genen betrokken bij het herstel van DNA via homologe recombinatie (HRR+ mHSPC).
• Radium-223 ^IND
• Rosopatamab tetraxetan lutetium (177Lu)

• 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.
  • Talzenna in combinatie met enzalutamide is geïndiceerd voor de eerstelijnsbehandeling van patiënten met een gemetastaseerd, hormoonsensitief HRR+ prostaatcarcinoom

Schildklierkanker

• Dabrafenib / trametinib

  • Treatment of differentiated thyroid cancer (DTC)

• Selpercatinib

  • Extension of indication to include to include paediatric patients 2 years and older with: (1) Advanced RET fusion-positive thyroid cancer who are radioactive iodine-refractory, (2) Advanced RET-mutant medullary thyroid cancer, (3) Advanced RET fusion-positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted.

Tumoragnostische geneesmiddelen

• MDM2-p53 antagonist

• Trastuzumab deruxtecan

  • Extension of indication to include treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment and who have no satisfactory alternative treatment options.

Onbekend

• Amisulpride

• Belzutifan

  • Belzutifan in combination with pembrolizumab as adjuvant treatment of clear cell renal cell carcinoma

• Daratumumab

  • Daratumumab in combination with lenalidomide for maintenance treatment of newly diagnosed Multiple myeloma in adults and elderly who are minimal residual disease positive after frontline autologous stem cell transplant.
• Emactuzumab
• Ivospemin

• Pembrolizumab

  • Pembrolizumab monotherapy in dMMR advanced or recurrent endometrial carcinoma.

• Selumetinib

  • 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.