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 comments
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 comments
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 comments
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 comments
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 comments
Fase 2 studie.

Other information

There is currently no futher information available.