Biosimilars, Clovis' Rubraca among CHMP recommendations
EMA's CHMP recommended approval of a basket of therapies including cancer drug Rubraca rucaparib from Clovis Oncology Inc. (NASDAQ:CLVS), two biosimilars and HIV therapy Juluca dolutegravir/rilpivirine from ViiV Healthcare Ltd. (Brentford, U.K.).
CHMP backed Rubraca's conditional approval to treat platinum-sensitive, BRCA-mutant relapsed or progressive ovarian cancer in a third-line setting. The oral inhibitor of PARP-1, PARP-2 and PARP-3 has accelerated approval in the U.S. as a third-line therapy for BRCA-mutant ovarian cancer, and is under FDA review as maintenance therapy for recurrent ovarian cancer following chemotherapy, regardless of BRCA mutation status (see BioCentury Extra, Dec. 5, 2017)...
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