ARTICLE | Clinical News
Positive CHMP vote likely for Clovis' PARP inhibitor
February 23, 2018 8:19 PM UTC
Clovis Oncology Inc. (NASDAQ:CLVS) said EMA's CHMP communicated a "positive trend vote" for an MAA for rucaparib (CO-338) to treat platinum-sensitive, BRCA-mutant advanced ovarian cancer. Clovis expects a formal vote on the MAA at CHMP's meeting March 19-22.
Pending European approval, Clovis hopes to submit a variation to the MAA to broaden rucaparib's label to include women with ovarian cancer regardless of BRCA mutation status. Rucaparib is an oral inhibitor of PARP-1, PARP-2 and PARP-3...