Posted by Michael Wonder on 17 Dec 2018
CHMP grants positive opinion for new indication of Clovis Oncology’s Rubraca (rucaparib) tablets as maintenance treatment for women with relapsed ovarian cancer
13 December 2018 - European Commission marketing authorisation is anticipated Q1 2019.
Clovis Oncology today announced that the European Union’s EMA's CHMP has adopted a positive opinion recommending an additional indication to include rucaparib as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
The CHMP’s positive opinion for this additional indication was based on data from the phase 3 ARIEL3 clinical trial, which found that rucaparib signicantly improved progression-free survival in all ovarian cancer patient populations studied.
