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Oncology
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4 June 2024
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Mechanism of action
Any mechanism of action
Unknown
Alkylating agent
Allergen
Allogeneic modified cell therapy
Amino acid
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LABA / LAMA / ICS
LAMA
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Oncolytic adenovirus
Other
Other, see general comments
PARP inhibitor
PD-1 / PD-L1 inhibitor
Proteasome inhibitor
Protein chaperone
Receptor agonist
Receptor antagonist
Serine / threonine kinase inhibitor
SGLT inhibitor
Small interfering RNA (siRNA)
Sodium channel blocker
Thrombin inhibitor
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
Abnobaviscum 900
G
Durvalumab
IND
Enfortumab vedotin
IND
Erdafitinib
Inbakicept
Nivolumab
Extension of indication to include in combination with cisplatin-based chemotherapy the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
IND
OPDIVO in combination with cisplatin-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
IND
Sacituzumab Govitecan
IND
Sasanlimab
Brain cancer
Dabrafenib / trametinib
Paclitaxel trevatide
Vorasidenib
Breast cancer
Atezolizumab
IND
Camizestrant
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
Inavolisib
IND
Olaparib
IND
Paclitaxel
Palbociclib
IND
Ribociclib
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
Vepdegestrant
Cervical cancer
Cadonilimab
Dostarlimab
IND
Olaparib
IND
Tisotumab vedotin
Colon cancer
Fruquintinib
Nivolumab
IND
Pembrolizumab / favezelimab
Trifluridine / tipiracil
IND
Head and neck cancer
Atezolizumab
IND
Leukocyte interleukin
Tislelizumab
IND
Xevinapant
Kidney cancer
Abexinostat
Belzutifan
Cabozantinib
IND
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
Namodenoson
Tremelimumab
Lung cancer
Adagrasib
Alectinib
IND
Amivantamab
Amivantamab in combination with carboplatin and pemetrexed for the first‑line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating EGFR Exon 20 insertion mutations.
IND
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 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
Subcutaneous formulation of atezolizumab for treatment of PD-(L)-1 Cancer Immunotherapy in multiple tumor types.
IND
Extension of indication to include first-line treatment of adult patients with non-small cell lung cancer (NSCLC) who are ineligible for platinum-based chemotherapy and who do not have EGFR mutant or ALK-positive disease, who have: locally advanced unresectable NSCLC not amenable for definitive chemoradiotherapy, or metastatic NSCLC.
IND
Aumolertinib (mesilate)
Cobolimab
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
Lokaal gevorderd, niet-resectabel NSCLC (stadium III)
IND
1L advanced NSCLC
IND
Limited stage small cell lung cancer (LS-SCLC) following concurrent platinum-based chemotherapy and radiation therapy in combination with Tremelimumab.
IND
Extension of indication to include IMFINZI in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy after surgery, for the treatment of adults with resectable (tumours ≥ 4 cm and/or node positive) NSCLC and no known EGFR mutations or ALK rearrangements.
IND
Encorafenib
IND
Ipilimumab
IND
Lazertinib
Lenvatinib
IND
Nintedanib
G
Nivolumab
OPDIVO in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥1%
IND
Extension of indication to include OPDIVO for the treatment of patients with resectable stage II-IIIB non-small cell lung cancer
IND
Ociperlimab
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
Extension of indication to include treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy.
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
Keytruda, in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non‑small cell lung carcinoma at high risk of recurrence in adults
IND
Retifanlimab
IND
Sacituzumab Govitecan
IND
Serplulimab
Sugemalimab
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.
Tiragolumab in combination with Atezolizumab for first line treatment of locally advanced unresectable or metastatic high PD-L1, EGFR-negative, ALK-negative Non-small cell lung cancer in adults and elderly.
Tislelizumab
Tizveni as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving 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
Tizveni in combination with pemetrexed and platinum‑containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous non-small cell lung cancer whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations and who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC
Extension of indication to include treatment of adult patients with non-small cell lung cancer (NSCLC) in combination and as monotherapy
IND
Toripalimab
IND
Trastuzumab deruxtecan
IND
Tremelimumab
Oncology other
AL102
Afamitresgene autoleucel
Catequentinib
Efbemalenograstim alfa
Entrectinib
IND
Futibatinib
Melphalan hydrochloride
NY-ESO-1 autologous engineered TCR-T cells
Nirogacestat
Nivolumab
IND
Pembrolizumab
Indication for treatment in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults.
IND
Extension of indication to include in combination with pemetrexed and platinum chemotherapy the first -line treatment of adults and adolescents aged 12 years and older with unresectable advanced or metastatic malignant pleural mesothelioma.
IND
Repotrectinib
Retifanlimab
Patiënten met inoperabele, lokaal gevorderd of gemetastaseerd plaveiselcarcinoom van het anale kanaal.
Zynyz is indicated as monotherapy for the first‑line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) not amenable to curative surgery or radiation therapy
Selinexor
IND
Sugemalimab
IND
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.
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)
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
Olaparib
IND
Rucaparib
IND
Pancreatic cancer
Gemcitabine
Irinotecan in gepegyleerde liposomen
IND
Prostate cancer
Aglatimagene besadenovec
Atezolizumab
IND
Degarelix
G
Enzalutamide
IND
Lutetium (177lu) vipivotide tetraxetan
Niraparib
IND
Niraparib / abirateron
Olaparib
IND
Radium-223
IND
Relugolix
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
Lifileucel
Nivolumab/relatlimab/hyaluronidase Ph20
Relatlimab / nivolumab
Tucidinostat
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
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
IND
Tumour agnostic medication
MDM2-p53 antagonist
Selpercatinib
IND
Trastuzumab Deruxtecan
IND
Unknown
Belzutifan
Decitabine / cedazuridine
IND
Mycofenolaatmofetil
IND
Pembrolizumab
IND
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