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7 May 2020

FDA Grants Accelerated Approval to Capmatinib for NSCLC

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The FDA granted accelerated approval to capmatinib (Tabrecta) for 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.

Efficacy for capmatinib was demonstrated in the multicenter, non-randomized, open-label, multi-cohort phase II GEOMETRY mono-1 trial, designed to evaluate the agent in 97 patients with metastatic NSCLC with confirmed METexon 14 skipping. Trial participants were given 400 mg of capmatinib orally twice daily until disease progression or unacceptable toxicity.

The primary outcome measure was overall response rate (ORR) determined by a blinded independent review committee using RECIST 1.1. Secondary outcome measures included duration of response (DOR), time to response, disease control rate, progression-free survival, and overall.

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