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Novartis' Capmatinib Gets Breakthrough Therapy Tag From FDA

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Novartis AG (NVS - Free Report) announced that the FDA has granted a Breakthrough Therapy designation to its MET inhibitor capmatinib (INC280) for the first-line treatment of patients with metastatic MET exon14 skipping-mutated non-small cell lung cancer (NSCLC). Currently, there is no approved therapy for this aggressive form of disease.

The Breakthrough Therapy designation is granted to speed up the development and review of drugs that target serious or life-threatening conditions.

This designation was assigned based on positive primary results from the GEOMETRY mono-1 study, which was presented at the annual meeting of the American Society of Clinical Oncology (ASCO) held in June this year. Data from the study showed that treatment with capmatinib demonstrated promising efficacy in patients with locally advanced or metastatic NSCLC that harbor MET exon-14 skipping mutation.

Overall response rate among treatment-naive patients receiving capmatinib was 68% and 41% for previously treated patients. The median duration of response was also clinically meaningful irrespective of the prior line of therapy.

Novartis plans to submit a regulatory filing for capmatinib in the United States in the fourth quarter of 2019. This Breakthrough Therapy designation now covers treatment-naïve patients as well as those previously treated with platinum-based chemotherapy.

Shares of Novartis have inched up 4.4% so far this year against the industry’s decrease of 0.7%.

We would like to remind investors that capmatinib is an investigational, oral and selective MET inhibitor, which has been licensed to Novartis by Incyte Corporation (INCY - Free Report) in 2009. Per the agreement, Incyte granted the company worldwide exclusive development/commercialization rights to capmatinib and certain back-up compounds in all indications.

Also, competition is stiff in the NSCLC market with several big pharma companies having approved drugs for the same. To name a few would be Merck’s (MRK - Free Report) Keytruda, AstraZeneca’s (AZN - Free Report) Tagrisso and Roche’s Tecentriq. Hence, if approved, capmatinib will face a strong rivalry from the above-mentioned drugs.

Zacks Rank

Novartis currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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