BTD in hand, Exelixis speeds cabo application to FDA

Just weeks after announcing promising trial data, South San Francisco-based Exelixis ($EXEL) says that the FDA has provided its breakthrough therapy designation for cabozantinib (approved as Cometriq) as a second-line treatment for kidney cancer. CEO Michael M. Morrissey says the BTD--designed to accelerate discussions with regulators--sets the stage for moving up its marketing application for renal cell carcinoma to sometime later this year. Exelixis posted positive progression-free survival data in late July. Release

Suggested Articles

Genor Biopharma banked $160 million from the likes of Hillhouse and Temasek Holdings to advance its clinical-stage autoimmune and cancer programs.

Going from being the CSO of Bristol Myers Squibb to running one of the biggest cancer research organizations in the world is a major career shift.

Hahn made the commitment in a speech that called on the FDA to learn from the crisis to enact lasting policies that accelerate drug development.