Clovis Oncology's Rubraca (Rucaparib) Receives EU Approval for Maintenance Treatment of Relapsed Ovarian Cancer (OC) in Adults
Shots:
- The approval is based on P-III ARIEL3 study results assessing Rubraca (600mg- bid) vs PBO in 564 women in a ratio (2:1) with a recurrent epithelial ovarian- fallopian tube or primary peritoneal cancer in complete or partial response to PT-based CT
- P-III ARIEL3 study results: PFS events (62% vs 88%); mPFS (10.8mos. vs 5.4mos.); In tBRCA Group: PFS events (52% vs 85%); mPFS (16.6mos. vs 5.4mos.)- CR 7%; Tumor response (18% vs 8%)
- Rubraca (rucaparib) is an inhibitor of PARP1- PARP2 and PARP3 targeted as a monothx or in combination for multiple tumor types- including ovarian- metastatic castration-resistant prostate and bladder cancers
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