Posted by Michael Wonder on 23 Mar 2018
CHMP grants positive opinion for Clovis Oncology's Rubraca (rucaparib) tablets
23 March 2018 - First PARP inhibitor recommended for treatment indication in the EU.
Clovis Oncology today announced that the European Union’s EMA CHMP has adopted a positive opinion recommending the granting of a conditional marketing authorisation for Rubraca as monotherapy treatment of 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.
The application for the treatment indication was based on objective response rate and duration of response results from two multi-center, single-arm, open-label clinical trials, Study 10 and ARIEL2, in women with advanced BRCA mutant ovarian cancer who had progressed after two or more prior chemotherapies.
