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Tepotinib

Tepmetko

Extended indication Indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbo
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Tepotinib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Lung cancer
Extended indication Indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations.
Proprietary name Tepmetko
Manufacturer Merck
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)
Type of trajectory Normal trajectory
Submission date November 2020
Expected Registration February 2022
Orphan drug No
Registration phase Registration application pending
Additional remarks Primary completion date in December 2021.

Therapeutic value

Therapeutic value No estimate possible yet
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 In 2018 waren er 10.190 diagnoses NSCLC in Nederland, hiervan heeft 10% stadium IIIb (1.090) en 50% stadium IV (5.095). Hier komen nog patiënten bij uit eerdere stadia die verslechteren naar stadium IIIb/IV. Binnen een jaar is de inschatting dat dit 20% van stadium I/II bedraagt (529) en 50% van stadium IIIa (713). In totaal bedraagt deze groep dus 7.427 patiënten. Hiervan heeft 77% een adenocarcinoom (5.719). 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.

Expected cost per patient per year

References NKR; R Heist. MET Exon 14 Skipping in Non-Small Cell Lung Cancer. Oncologist. 2016; https://pubmed.ncbi.nlm.nih.gov/32642122/; Bubendorf L, Dafni U, Schobel M, Finn SP, Tischler V, Sejda A, et al. Prevalence and clinical association of MET gene overexpression and amplification in patients with NSCLC: Results from the European Thoracic Oncology Platform (ETOP) Lungscape project. Lung cancer (Amsterdam, Netherlands). 2017;111:143-9

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.