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FDA Grants Priority Review for Exelixis' RCC Drug Cabomteyx

Exelixis, Inc.EXEL announced that the FDA has granted priority review to its supplemental New Drug Application (sNDA) for Cabomteyx. The sNDA seeks approval of Cabometyx for patients with previously untreated advanced renal cell carcinoma (RCC). The FDA determined the sNDA to be sufficiently complete.

Consequently, the FDA assigned a Prescription Drug User Fee Act action date of Feb 15, 2018.

The sNDA is based on data from the phase II trial, CABOSUN, which is being conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis' collaboration with the National Cancer Institute's Cancer Therapy Evaluation Program.

The market for advanced RCC is huge. Per the American Cancer Society's 2017 statistic data, clear cell RCC is the most common type of kidney cancer in adults. 30,000 patients in the United States and 68,000 globally require treatment, and an estimated 14,000 patients in the United States are in need of a first-line treatment for advanced kidney cancer every year.

We remind investors that Cabometyx was approved by the FDA in April 2016 for the treatment of patients with advanced RCC who received prior anti-angiogenic therapy.

New patient starts, refills for patients already on therapy and continued expansion of the prescriber base for Cabometyx are driving the drug's sales. Hence, a potential approval of Cabometyx is expected to boost sales.

Concurrently, Exelixis and partner Ipsen announced that the phase III trial, CELESTIAL, met its primary endpoint of overall survival (OS), with cabozantinib providing a statistically significant and clinically meaningful improvement in median OS compared to placebo in patients with advanced hepatocellular carcinoma (HCC). Consequently, the independent data monitoring committee for the study recommended that the trial should be stopped for efficacy following review of the second planned interim analysis.

The company's shares moved up 17.2% following the news. Exelixis' share price has increased 94.6% year to date, higher than the industry's gain of 14.0%.

Exelixis has collaborated with Bristol-Myers Squibb Co. BMY and Roche Holdings RHHBY for the development of the drug in combination with immunotherapy agents

We note that GlaxoSmithKline plc's GSK Votrient is also approved for clear cell RCC.

Zacks Rank

Exelixis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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