Posted by Michael Wonder on 05 Jul 2018
Clovis Oncology receives EMA validation for its application for a new indication for Rubraca (rucaparib) as maintenance treatment for women with recurrent ovarian cancer
5 July 2018 - The filing is based on positive phase 3 ARIEL3 clinical trial data in which rucaparib significantly improved progression free survival compared to placebo in all primary efficacy ovarian cancer patient populations.
Clovis Oncology today announced that the EMA has validated the application for a Type II variation to the marketing authorisation 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. This validation confirms the submission is complete and begins the EMA’s centralised review process.
Based on the timing of this submission, the company anticipates an opinion from the CHMP by end of 2018.
