BioCentury
ARTICLE | Company News

Priority Review for Exelixis' cabozantinib in RCC

January 29, 2016 2:29 AM UTC

Exelixis Inc. (NASDAQ:EXEL) said FDA granted Priority Review to an NDA for a tablet formulation of cabozantinib ( XL184) as second-line therapy to treat advanced renal cell carcinoma. Its PDUFA date is June 22. Exelixis said the agency has deemed the submission "sufficiently complete," but will not officially accept it for filing until Feb. 20.

Also on Thursday, Exelixis said EMA accepted its MAA for cabozantinib in the same indication. ...