Clovis' rucaparib gains breakthrough designation
FDA granted Clovis Oncology Inc. (NASDAQ:CLVS) breakthrough therapy designation for rucaparib ( CO-338) as monotherapy in patients with germline or somatic BRCA-mutated advanced ovarian cancer who have received at least two prior platinum-containing therapies. The company plans to submit an NDA in 2016 for the oral inhibitor of poly(ADP-ribose) polymerase-1 ( PARP-1) and PARP-2.
FDA based the designation on interim results from two ongoing Phase II trials. Results from one, ARIEL2, were presented last week at the Annual Meeting on Women's Cancer in Chicago and showed that among rucaparib-treated patients with advanced, platinum-sensitive ovarian cancer with germline or somatic BRCA mutations, 70% achieved a RECIST response and/or CA-125 response and 65% achieved a RECIST response. ...