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Tepotinib

Extended indication Patients with locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) naïve in first-line
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Tepotinib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Lung cancer
Extended indication Patients with locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) naïve in first-line or pretreated patients with no more than 2 lines of prior therapy.
Manufacturer Merck/Pfizer
Mechanism of action Other
Route of administration Oral
Budgetting framework Intermural (MSZ)
Additional remarks Proto oncogene protein c-Met inhibitor

Registration

Registration route Centralised (EMA)
Submission date 2021
Expected Registration 2022
Registration phase Clinical trials
Additional remarks Primary completion datum in december 2021.

Therapeutic value

Therapeutic value No judgement
Substantiation De verwachting is dat tepotinib in de toekomst mogelijk de concurrentie met capmatinib aan zal gaan.
Frequency of administration 1 times a day
Dosage per administration 500 mg
References NCT02864992
Additional remarks Once daily in cycles of 21-day duration until disease progression, death, adverse event (AE).

Expected patient volume per year

Patient volume

200 - 300

Market share is generally not included unless otherwise stated.
References NKR; R Heist. MET Exon 14 Skipping in Non-Small Cell Lung Cancer. Oncologist. 2016; https://pubmed.ncbi.nlm.nih.gov/32642122/
Additional remarks Jaarlijks presenteren er ongeveer 7.500 patiënten per jaar met NSCLC stadium IIIb/IV. In 2018 registreerde IKNL 32 MET mutaties in de eerste lijn. Maar dit aantal is onvolledig omdat er nog niet standaard op MET getest werd, en er ook gevallen gediagnostiseerd kunnen worden in tweede lijn. MET exon 14 skipping ligt in de range van 1,5%-6% van alle NSCLC patiënten. Een recente Franse studie meldt 2.6% positieve uitslagen bij geteste patiënten met NSCLC-IV. Uitgaande van bovenstaande getallen is de verwachting dat er zo'n 200-300 patiënten in aanmerking zullen komen voor deze behandeling.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Liver cancer
References adisinsght
Additional remarks Fase 2 studie

Other information

There is currently no futher information available.