FDA approves Keytruda for first-line melanoma

Merck & Co. Inc. (NYSE:MRK) said FDA approved a label expansion for Keytruda pembrolizumab to include first-line treatment in patients with advanced melanoma. The humanized IgG4 mAb against PD-1 is approved to treat melanoma in patients previously treated with Yervoy ipilimumab, as well as advanced squamous and non-squamous NSCLC in patients with PD-L1-positive tumors.

FDA based its approval on data from the Phase III KEYNOTE-006 study, in which Keytruda was superior to Yervoy in improving overall survival (OS) and progression-free survival (PFS) to treat advanced melanoma (see BioCentury Extra, March 24). ...