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Exelixis Starts Cometriq Rolling NDA Filing for Kidney Cancer

Exelixis, Inc.EXEL announced that it has started submitting a rolling new drug application (NDA) to the FDA for its oncology drug Cometriq (cabozantinib). The company is looking to get Cometriq approved for the treatment of patients suffering from advanced renal cell carcinoma (RCC) who have received one prior therapy.

We note that a rolling submission will allow the company to complete portions of the application which needs to be submitted and reviewed by the FDA on an ongoing basis. Exelixis expects to complete the submission of the application by year end. Cometriq enjoys both Fast Track and Breakthrough Therapy designations for advanced RCC in the U.S., which should expedite its development process.

Cometriq is already approved in the U.S. for the treatment of progressive, metastatic medullary thyroid cancer (MTC). Additionally, it has been granted conditional approval in the EU for the treatment of adults with progressive, unresectable locally advanced or metastatic MTC.

We are encouraged by Exelixis' label expansion efforts. Cometriq registered sales of $17.4 million in the first half of 2015. Taking into account the number of RCC patients eligible for treatment with Cometriq, we believe label expansion will boost the drug's sales.

Meanwhile, Exelixis is also evaluating Cometriq across different types of cancer including advanced hepatocellular carcinoma among others.

We expect investor focus to remain on Cometriq's sales ramp up and the company's label expansion efforts.

Exelixis carries a Zacks Rank #2 (Buy). Some favorably ranked stocks in the health care sector are AstraZeneca Plc AZN , Actelion Ltd. ALIOF and Amgen Inc. AMGN . All three carry a Zacks Rank #1 (Strong Buy).

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EXELIXIS INC (EXEL): Free Stock Analysis Report

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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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