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FDA Approved: Tabrecta (capmatinib) tablets

TABRECTA tablets is indicated 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.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

FoundationOne®CDx is the FDA-approved companion diagnostic test for TABRECTA.

Please see the clinical safety and efficacy information below and attached associated with TABRECTA. 

Please see full Prescribing Information for TABRECTA.

Novartis US Media Release - Tabrecta

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