Thursday July 5, 2018 0 comments
BOULDER -- Clovis Oncology, Inc. (NASDAQ: CLVS) announced the European Medicines Agency (EMA) has validated the application for a Type II variation to the marketing authorization for Rubraca® (rucaparib) to include maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum based chemotherapy.
The validation confirms the submission is complete and begins the EMA’s centralized review process, Clovis said.
“We are very pleased to receive validation of the variation to the Rubraca marketing authorization by the EMA, which brings us a step forward in making rucaparib available to more women with recurrent ovarian cancer in Europe,” said Patrick J. Mahaffy, Clovis CEO and president.
Clovis said the submission is based on positive results from the phase 3 ARIEL3 study, which evaluated rucaparib in the ovarian cancer maintenance treatment setting among three populations: 1) BRCA mutant (BRCAmut+) 2) HRD positive inclusive of BRCAmut+ and, 3) all patients treated in ARIEL3. ARIEL3 successfully achieved its primary endpoints, extending investigator assessed progression-free survival (PFS) versus placebo in all patients treated, regardless of BRCA status.
Safety findings from the ARIEL3 trial were consistent with previous clinical trials, Clovis noted.
In May, rucaparib was granted Marketing Authorization in Europe for adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy.
Based on the timing of this submission, Clovis said it anticipates an opinion from the Committee for Medicinal Products for Human Use (CHMP) by the end of 2018.