BioCentury
ARTICLE | Clinical News

Biosimilars, Clovis' Rubraca among CHMP recommendations

March 30, 2018 5:47 PM UTC

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 , Dec. 7, 2017)...