10:47 AM
Mar 30, 2018
 |  BC Week In Review  |  Clinical News  |  Regulatory

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 , Dec. 7, 2017).

The committee favored approval of Kanjinti trastuzumab (APB 980) from Amgen Inc. (NASDAQ:AMGN) and Allergan plc (NYSE:AGN), a biosimilar of Herceptin trastuzumab from...

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