25 August 2015 - Exelixis, Inc. today announced the U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy Designation to cabozantinib maleate, Exelixis’ lead compound, as a potential treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy. Created in 2012, FDA’s Breakthrough Therapy Designation expedites the development and review of drugs that are intended to treat serious or life-threatening diseases, and for which preliminary clinical evidence indicates the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Drugs that receive Breakthrough Therapy Designation may benefit from involvement of FDA senior managers in the review process, potential rolling submission and/or Priority Review of a sponsor’s New Drug Application (NDA), and other benefits.

“Receiving Breakthrough Therapy Designation is an important regulatory achievement for cabozantinib maleate in renal cell carcinoma,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “Following the positive top-line results announced in July and a productive dialogue with the FDA, Exelixis believes we can expedite our regulatory timelines and complete the cabozantinib maleate NDA submission in advanced RCC prior to the end of 2015. We look forward to working closely with the FDA during the submission and review process, keeping in mind our ultimate goal of bringing a new therapeutic option to the renal cell carcinoma community as soon as possible.”

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