Posted by Michael Wonder on 04 Jun 2018
Clovis Oncology submits application to EMA to expand use of Rubraca (rucaparib) to include maintenance treatment for women with recurrent ovarian cancer
4 June 2018 - Submission based on positive phase 3 ARIEL3 clinical trial in which rucaparib significantly improved PFS in all primary efficacy ovarian cancer patient populations studied.
Clovis Oncology today announced the submission of a regulatory application to the EMA, as part of a type II variation seeking to expand 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.
Based on the timing of this submission, the company anticipates an opinion from the CHMP by end of 2018.
