Capmatinib (Tabrecta)

General information

Class/mechanism: Small molecule tyrosine kinase inhibitor, oral cMET inhibitor. Inhibits MET (mesenchymal-epithelial transition), including the mutant variant which results from exon 14 skipping. Cells with MET exon 14 skipping have a protein with a missing regulatory domain, which results in reduced negative regulation and therefore increased downstream MET signaling. Capmatinib was demonstrated to inhibit cancer cell growth driven by a mutant MET variant lacking exon 14.
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

• Capmatinib (Tabrecta) package insert

History of changes in FDA indication

• 2020-05-06: FDA accelerated approval for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. (Based on GEOMETRY mono-1)
  • 2022-08-10: Regular approval for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping. (Based on GEOMETRY mono-1)

History of changes in EMA indication

• 2022-06-20: Initial authorization as Tabrecta. Tabrecta 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. (Based on GEOMETRY mono-1)

History of changes in Health Canada indication

• 2022-05-26: 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) exon 14 skipping alterations.

History of changes in PMDA indication

• 2020-06-29: 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: INC-280
• Generic name: capmatinib
• Brand names: Tabrecta