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Potential Lung Cancer Drug from Incyte and Novartis to Get a Priority Review from FDA

By Cory Renauer – Feb 11, 2020 at 10:45AM

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The Food and Drug Administration will expedite its review of capmatinib.

Patients with a particularly aggressive form of lung cancer could have a new, easy-to-swallow treatment option this summer called capmatinib. The first New Drug Application for the experimental treatment, which Novartis (NVS -1.72%) licensed from Incyte (INCY 0.20%), will receive a priority review from the FDA that will shave at least four months off the decision-making process.

After Incyte completed a phase 1 clinical trial of capmatinib in 2012, Novartis took control of the drug's development. While it doesn't seem like Novartis was in a rush to send in its application to the FDA, capmatinib could jump straight to the head of the class as a treatment for patients with MET exon 14 skipping (METex14) mutated non-small cell lung cancer.

Two scientists working in the lab.

Image source: Getty Images.

Between 7,000 and 8,000 people in the U.S. are diagnosed annually with lung cancers driven by METex14 mutations, and these tumors tend to be very aggressive. Based on evidence that Novartis used to support capmatinib's new drug application, taking the tablet daily shrank tumors for 68% of first-line patients. 

Investigators also gave capmatinib to patients with stubborn tumors that had continued to grow after they had been given the current standard-of-care treatment. The tablet shrank tumors for 41% of people in this hard-to-treat group.

When a drug causes patients' tumors to shrink, it's a good sign that it will improve their chances of long-term survival, but it's just a sign. If capmatinib is granted approval this summer, as is expected, its commercial future will be determined by the durability of the responses we've seen so far. 

If capmatinib does become a commercial success, Novartis will pay royalties of between 12% and 14% of global sales to Incyte.

Cory Renauer has no position in any of the stocks mentioned. The Motley Fool recommends Incyte. The Motley Fool has a disclosure policy.

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Incyte Corporation Stock Quote
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INCY
$69.64 (0.20%) $0.14
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