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Oncology
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5 December 2023
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Mechanism of action
Any mechanism of action
Unknown
Alkylating agent
Allergen
Allogeneic modified cell therapy
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Other
Other, see general comments
PARP inhibitor
PD-1 / PD-L1 inhibitor
Proteasome inhibitor
Protein chaperone
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Serine / threonine kinase inhibitor
SGLT inhibitor
Small interfering RNA (siRNA)
Sodium channel blocker
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TNF-alpha inhibitor
Tyrosine kinase inhibitor
Vasodilator
Virus inhibitor
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
Atezolizumab
IND
Capivasertib
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.
IND
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.
IND
Elacestrant
Paclitaxel
Palbociclib
IND
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.
IND
Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer
IND
Sacituzumab govitecan
IND
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
Dostarlimab
IND
Colon cancer
Eflornithine / sulindac
Fruquintinib
Pembrolizumab / favezelimab
Trifluridine / tipiracil
IND
Head and neck cancer
Atezolizumab
IND
Leukocyte interleukin
Tislelizumab
IND
Xevinapant
Kidney cancer
Atezolizumab
IND
Belzutifan
Ilixadencel
Liver cancer
Atezolizumab
IND
Durvalumab
Durvalumab (+/- bevacizumab) in combinatie met TACE in patiënten met locoregionale HCC.
IND
Imfinzi as monotherapy is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).
IND
Tremelimumab
Lung cancer
Adagrasib
Alectinib
IND
Amivantamab
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.
IND
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).
IND
Atezolizumab
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)
Cemiplimab
IND
Datopotamab deruxtecan
Datopotamab deruxtecan, in combination with Pembrolizumab, is indicated for the treatment of adult patients with advanced or metastatic NSCLC without actionable genomic alterations whose tumor has high programmed death-ligand 1 (PD-L1) expression (tumor proportion score; TPS ≥50%) and who have not previously received systemic therapy for advanced or metastatic NSCLC.
IND
Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer, who have received at least one systemic therapy
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
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
Ipilimumab
IND
Lazertinib
Nintedanib
G
Nivolumab
IND
Osimertinib
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.
IND
Stage III unresectable Epidermal Growth Factor Receptor (EGFR) mutation positive non-small cell lung cancer (NSCLC)
IND
Pembroliuzmab
IND
Pembrolizumab
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.
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
Entrectinib
IND
Futibatinib
Igrelimogene litadenorepvec
Ivosidenib
Melphalan hydrochloride
Nirogacestat
Nivolumab
IND
Pembrolizumab
IND
Retifanlimab
Selinexor
IND
Sodium thiosulfate
Tebentafusp
Tislelizumab
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.
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
IND
Mirvetuximab soravtansine
Rucaparib
IND
Pancreatic cancer
Gemcitabine
Irinotecan in gepegyleerde liposomen
IND
Prostate cancer
Atezolizumab
IND
Darolutamide
IND
Degarelix
G
Enzalutamide
IND
Gozetotide
Lutetium (177lu) vipivotide tetraxetan
Niraparib
IND
Niraparib / abirateron
Olaparib
IND
Rucaparib
IND
Talazoparib
IND
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.
IND
Neoadjuvant Ipilimumab Plus Nivolumab in Macroscopic Stage III Melanoma.
IND
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
Tavokinogene telseplasmid
Stomach cancer
Catumaxomab
Domvanalimab
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 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.
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.
IND
Retsevmo is als monotherapie geïndiceerd voor de behandeling van volwassenen en adolescenten van 12 jaar en ouder met gevorderd RET-gemuteerd medullair schildkliercarcinoom (MTC).
IND
Tumour agnostic medication
Selpercatinib
IND
Unknown
Binimetinib/encorafenib
IND
Olaparib
IND
Pembrolizumab
IND
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