Tepotinib (Tepmetko)

General information

Class/mechanism: C-Met inhibitor. Inappropriate or constitutive activation of the receptor tyrosine kinase c-Met and its signalling pathway is implicated in many cancers, playing a role in abnormal proliferation, survival, invasion, metastasis, and angiogenesis.^[1]^[2]^[3]
Route: PO
Extravasation: n/a

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is used

Non-small cell lung cancer, MET-mutated

Patient drug information

History of changes in FDA indication

2021-02-03: Granted accelerated approval for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. (Based on VISION_NSCLC)
2024-02-15: Granted full approval for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. (Based on VISION_NSCLC)

History of changes in EMA indication

2022-02-16: Initial authorization as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

History of changes in Health Canada indication

2021-05-27: Initial notice of compliance with conditions for the treatment of adult patients with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) tyrosine kinase receptor exon 14 skipping alterations.

History of changes in PMDA indication

2020-03-25: Newly indicated for the treatment of unresectable advanced or recurrent MET exon 14 (METex14) skipping mutation-positive non-small cell lung cancer.

Also known as

Code names: EMD-1214063, MSC-2156119, MSC-2156119J
Brand name: Tepmetko

References

[insert-1] 1.0 ^1.1 Tepotinib (Tepmetko) package insert

[2] Tepotinib (Tepmetko) package insert (locally hosted backup)

[3] Tepmetko manufacturer's website

[4] Tepotinib (Tepmetko) patient drug information (UpToDate)

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