September 06, 2019
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FDA grants breakthrough therapy designation to capmatinib for lung cancer subset

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The FDA granted breakthrough therapy designation to capmatinib for first-line treatment of metastatic MET exon 14 skipping-mutated non-small cell lung cancer.

MET mutations — identified in approximately 4% of patients with NSCLC — are associated with poor prognosis. The mutations, typically seen among older patients, can limit treatment options.

No targeted therapies are approved to treat MET exon 14 skipping-mutated NSCLC, an aggressive subtype of the disease.

Prior studies have shown capmatinib (INC280, Novartis) — an investigational, oral MET inhibitor — to be highly selective and potent in this setting, according to a Novartis-issued press release. The FDA previously granted breakthrough therapy designation to the agent for treatment of patients with this type of NSCLC who received prior platinum-based chemotherapy.

“We look forward to working with the FDA and global health authorities to bring capmatinib to patients who currently have no available targeted therapy options,” John Tsai, MD, head of global drug development and chief medical officer of Novartis, said in the release.