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Experimental Novartis drug secures FDA Breathrough designation for rare lung cancer

Published on 06/09/19 at 11:50am

Novartis is celebrating the acceptance of its experimental cancer drug capmatinib by the FDA onto an accelerated review pathway, securing the regulator’s coveted Breakthrough Therapy designation.

The pharma giant’s drug will now enter review as a first-line treatment of metastatic MET exon14 skipping-mutated non-small cell lung cancer (NSCLC), a rare mutated form which accounts for 3-4% of lung cancer cases.

The decision means that Novartis will be gearing up to take on Pfizer’s Xalkori, which also secured fast-track designation last year.

“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,” commented John Tsai, Novartis’s Chief Drug Developer.

Matt Fellows

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