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Oncology
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6 June 2023
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7 June 2022
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Mechanism of action
Any mechanism of action
Unknown
Alkylating agent
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Allogeneic modified cell therapy
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Other, see general comments
PARP inhibitor
PD-1 / PD-L1 inhibitor
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Serine / threonine kinase inhibitor
SGLT inhibitor
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Budgetting framework
Any budgetting framework
Unknown
Extramural (GVS)
Intermural (MSZ)
Particularity
Any particularity
Unknown
New medicine with Priority Medicines (PRIME)
New therapeutical formulation
Reason of inclusion
New medicines
Indication extensions
IND
Biosimilars / generics
BS
G
Download
Bladder cancer
Durvalumab
Neo-adjuvant durvalumab met chemotherapie en adjuvant durvalumab voor behandeling in patiënten met spier invasieve blaaskanker.
IND
Unresectable locally advanced or metastatic urothelial cancer in combination with tremelimumab and chemotherapy
IND
Enfortumab vedotin
IND
Erdafitinib
Inbakicept
Nivolumab
IND
Brain cancer
Dabrafenib / trametinib
Breast cancer
Abemaciclib
IND
Atezolizumab
IND
Balixafortide
Capivasertib
Elacestrant
Neratinib
IND
Olaparib
IND
Paclitaxel
Palbociclib
IND
Pembrolizumab
IND
Sacituzumab govitecan
For adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for advanced disease
Extension of indication to include treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
IND
Tesetaxel
Trastuzumab deruxtecan
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.
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
IND
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.
IND
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.
IND
Trastuzumab duocarmazine
Cervical cancer
Cadonilimab
Cemiplimab
IND
Lifileucel
Colon cancer
Eflornithine / sulindac
Fruquintinib
Trifluridine / tipiracil
Head and neck cancer
Atezolizumab
IND
Leukocyte interleukin
Tislelizumab
IND
Kidney cancer
Atezolizumab
IND
Belzutifan
Ilixadencel
Lenvatinib
IND
Pembrolizumab
Extension of indication for Keytruda to include in combination with lenvatinib first line treatment of adults with advanced renal cell carcinoma (RCC).
IND
Keytruda as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions.
IND
Liver cancer
Atezolizumab
IND
Durvalumab
Durvalumab (+/- bevacizumab) in combinatie met TACE in patiënten met locoregionale HCC.
IND
Imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).
IND
Tremelimumab
Lung cancer
Adagrasib
Atezolizumab
Tecentriq as monotherapy is indicated as adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with NSCLC with a high risk of recurrence whose tumours have PD-L1 expression on ≥ 50% of tumour cells (TC) and who do not have EGFR mutant or ALK‑positive NSCLC
IND
Atezolizumab subcutaneous in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC).
IND
Neoadjuvant atezolizumab with chemotherapy in patients with resectable stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC).
IND
Aumolertinib (mesilate)
Cabozantinib
IND
Capmatinib
Cemiplimab
Libtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ≥ 50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC.
IND
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.
IND
Domvanalimab
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.
IND
1L advanced NSCLC
IND
Completely resected NSCLC
IND
Lokaal gevorderd, niet-resectabel NSCLC (stadium III)
IND
Limited stage small cell lung cancer (LS-SCLC) following concurrent platinum-based chemotherapy and radiation therapy in combination with Tremelimumab.
IND
Ensartinib
Lenvatinib
IND
Nintedanib
G
Nivolumab
IND
OSE-2101
Osimertinib
Osimertinib with platinum plus pemetrexed chemotherapy as first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
IND
Stage III unresectable Epidermal Growth Factor Receptor (EGFR) mutation positive non-small cell lung cancer (NSCLC)
IND
Pembrolizumab
Extension of indication to include Keytruda as monotherapy for the adjuvant treatment of adults with Stage IB (T2a ≥ 4 cm), II or IIIA non-small cell lung carcinoma (NSCLC) who have undergone complete resection.
IND
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.
IND
Selpercatinib
IND
Serplulimab
Sugemalimab
Tislelizumab
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
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
Toripalimab
IND
Trastuzumab deruxtecan
IND
Tremelimumab
Oncology other
AL102
Afamitresgene autoleucel
Durvalumab
IND
Efbemalenograstim alfa
Erdafitinib
Futibatinib
Glucarpidase
Ivosidenib
Jodium (131I) omburtamab
Lenvatinib
IND
Melphalan hydrochloride
Nirogacestat
Pembrolizumab
Extension of indication to include pembrolizumab in combination with lenvatinib for the treatment of advanced endometrial carcinoma in adults who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation.
IND
Keytruda as monotherapy is indicated for the treatment of the following MSI‑H or dMMR tumours in adults with: unresectable or metastatic colorectal cancer after previous fluoropyrimidine‑based combination therapy; advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum‑containing therapy in any setting and who are not candidates for curative surgery or radiation; unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.
IND
indication for treatment with pembrolizumab plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma
IND
Retifanlimab
Selinexor
IND
Sodium thiosulfate
Tebentafusp
Tislelizumab
2L locally advanced or metastatic ESCC (esophageal squamous-cell carcinoma)
1L locally advanced or metastatic ESCC (esophageal squamous-cell carcinoma)
Toripalimab
Toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma (“NPC”)
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”)
Ovarian cancer
Dostarlimab
Stage III or IV non mucinous epithelial ovarian, fallopian tube, or peritoneal cancer (collectively referred to as "ovarian cancer")
IND
Extension of indication to include in combination with platinum -containing chemotherapy 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
IND
Mirvetuximab soravtansine
Rucaparib
IND
Prostate cancer
Atezolizumab
IND
Darolutamide
IND
Degarelix
G
Enzalutamide
IND
Gozetotide
Lutetium (177lu) vipivotide tetraxetan
Masitinib
Niraparib / abirateron
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.
IND
treatment of adults with metastatic castration resistant prostate cancer (mCRPC), with Lynparza in combination with abiraterone and prednisone or prednisolone
IND
Talazoparib
IND
Skin cancer
Darleukin fibromun
Ipilimumab
IND
Lenvatinib
IND
Lifileucel
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).
IND
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.
IND
Pembrolizumab
IND
Relatlimab / nivolumab
Tavokinogene telseplasmid
Stomach cancer
Catumaxomab
Domvanalimab
Nivolumab
IND
Pembrolizumab
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
IND
Extension of indication to include in combination with chemotherapy the first -line treatment of locally advanced unresectable or metastatic HER2 -negative gastric or gastrooesophageal junction adenocarcinoma in adults.
IND
Treatment in the neoadjuvant or adjuvant setting of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
IND
Tislelizumab
IND
Trastuzumab deruxtecan
IND
Zolbetuximab
Thyroid cancer
Selpercatinib
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 for Retsevmo.
IND
Retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced RET mutant medullary thyroid cancer (MTC)
IND
Tumour agnostic medication
Selpercatinib
IND
Unknown
Dasatinib
IND
Ibrutinib
IND
Tagraxofusp
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