EMA to review Merck's pembrolizumab for melanoma

EMA accepted for review an MAA for pembrolizumab ( MK-3475) from Merck & Co. Inc. (NYSE:MRK) to treat advanced melanoma. Merck declined to comment on when it expects a decision in Europe. A BLA for pembrolizumab is also under Priority Review in the U.S. for advanced melanoma in patients previously treated with Yervoy ipilimumab from Bristol-Myers Squibb Co. (NYSE:BMY). The PDUFA date is Oct. 28. Merck said it plans to submit regulatory applications in countries outside of Europe by year end, but declined to disclose details. The product is a humanized IgG4 mAb against PD-1 receptor ( PDCD1; PD-1; CD279). ...