Exelixis’s Cabozantinib Granted Priority Review in the U.S.

Exelixis, Inc. EXEL announced that the FDA has accepted the company’s rolling New Drug Application (NDA) application for cabozantinib for review. Exelixis is looking to get cabozantinib approved for the treatment of patients with advanced renal cell carcinoma (RCC) who have received a prior therapy.

The FDA has granted priority review to the NDA and intends to respond on the approval status of cabozantinib by Jun 22, 2016. Cabozantinib was granted Breakthrough Therapy and Fast Track designation in the U.S. for the proposed indication.

Exelixis said that the European Medicines Agency (EMA) has also accepted for review the Marketing Authorization Application (MAA) for cabozantinib for the same indication.

Cabozantinib has been granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP) which means a review period of 150 days instead of the standard review period of 210 days.

The approval of cabozantinib will be a major boost for the company. According to the American Cancer Society (2015 statistics), kidney cancer is one of the top ten common forms of cancer in the U.S., among both men and women. Information provided by the American Cancer Society indicates that the five-year survival rate is high for RCC patients when detected early; however, it falls below 10% in patients with advanced or late-stage metastatic RCC.

We note that cabozantinib is currently marketed by Exelixis in the U.S. under the brand name Cometriq for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). Meanwhile, Cometriq has conditional approval in the EU for the treatment of patients with progressive, unresectable locally advanced or metastatic MTC.

Exelixis is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. ANIK, Fate Therapeutics, Inc. FATE and Array BioPharma Inc. ARRY. All three carry a Zacks Rank #1 (Strong Buy).

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