Clovis Oncology Receives EMA Validation for its Application for a New Indication for Rubraca®? (rucaparib) as Maintenance Treatment for Women with Recurrent Ovarian Cancer
Clovis Oncology, Inc. (CLVS)
Last clovis oncology, inc. earnings: 2/24 04:05 pm
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Source: Business Wire
The filing is based on positive phase 3 ARIEL3 clinical trial data in which rucaparib significantly improved progression free survival (PFS) compared to placebo in all primary efficacy ovarian cancer patient populations Timing of validation by EMA may allow for a CHMP opinion on maintenance treatment by year-end 2018 BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that 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. This validation confirms the submission is complete and begins the EMA’s centralized review process. “We a
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