CHMP recommends host of therapies
EMA's CHMP issued opinions backing marketing authorization for a basket of compounds on Friday, including recommendations for cancer products from Amgen Inc. (NASDAQ:AMGN) and the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) as well as a cystic fibrosis therapy from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX).
Cancer products backed by CHMP included Amgen's Kyprolis carfilzomib, a selective proteasome inhibitor to treat relapsed multiple myeloma (MM); and MEK inhibitor Cotellic cobimetinib to treat metastatic melanoma. Genentech has worldwide rights to Cotellic from Exelixis Inc. (NASDAQ:EXEL). The committee also recommended conditional approval of Amgen's Blincyto blinatumomab, a bispecific T cell engager (BiTE) against CD19 to treat Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL). ...