Keytruda-Inlyta combo under Priority Review for first-line RCC

Merck & Co. Inc. (NYSE:MRK) said FDA accepted and granted Priority Review to its sBLA for Keytruda pembrolizumab plus Inlyta axitinib as a first-line treatment for renal cell carcinoma. Its PDUFA date is June 20.

The sBLA includes data from the Phase III KEYNOTE-426 study, in which the combination led to benefits in overall survival and progression-free survival (PFS) vs. Sutent sunitinib from Pfizer Inc. (NYSE:PFE) (see "Keytruda, Inlyta Combo Headed for First-Line RCC Submissions")...