US Breakthrough designation for Exelixis' cabozantinib for RCC

The US Food and Drug Administration has granted Breakthrough Therapy designation to cabozantinib, US pharma company Exelixis’ (Nasdaq: EXEL) lead compound, as a potential treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy.

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, and other benefits.

“Receiving Breakthrough Therapy Designation is an important regulatory achievement for cabozantinib in renal cell carcinoma,” said Michael Morrissey, president and chief executive 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 NDA submission in advanced RCC prior to the end of 2015.”