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. ...