Tepotinib

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.

Product

Manufacturer

Merck/Pfizer

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)

Submission date

2021

Expected Registration

2022

Registration phase

Clinical trials

Additional comments
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.

Duration of treatment

Not found

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
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 comments
Fase 2 studie

Other information

There is currently no futher information available.