FDA approves Exelixis' Cabometyx for RCC

FDA approved an NDA from Exelixis Inc. (NASDAQ:EXEL) for a tablet formulation of Cabometyx cabozantinib ( XL184) as second-line therapy to treat advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy. The approval, which comes well ahead of Cabometyx's June 22 PDUFA date, was based on data from the Phase III METEOR trial to treat advanced or metastatic RCC.

Exelixis said it has an 80-person sales team for Cabometyx and plans to launch the once-daily drug within two weeks. The wholesale acquisition price is $13,750 for a 30-tablet bottle. According to Cabometyx's label, the median duration of Cabometyx treatment in METEOR was 7.6 months. ...