Merck begins rolling BLA for MK-3475

Merck & Co. Inc. (NYSE:MRK) began submission of a rolling BLA to FDA for MK-3475 to treat advanced melanoma in patients previously treated with Yervoy ipilimumab from Bristol-Myers Squibb Co. (NYSE:BMY). Merck said it expects to complete the submission this half. The humanized IgG4 mAb against PD-1 receptor ( PDCD1; PD-1; CD279) is in Phase III testing for advanced melanoma, for which the compound has breakthrough therapy designation from FDA. MK-3475 is also in Phase II/III testing to treat previously treated non-small cell lung cancer (NSCLC). ...