Clovis Seeks FDA Approval for Rubraca as Ovarian Cancer Maintenance Therapy

Clovis Seeks FDA Approval for Rubraca as Ovarian Cancer Maintenance Therapy
Clovis Oncology seeks to expand its approval for Rubraca (rucaparib) to include maintenance therapy for women with recurrent ovarian cancer who respond to platinum-based chemotherapy. The company, based in Boulder, Colorado, has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and plans to seek similar approval from the European Medicines Agency (EMA) in early 2018. “The submission of the sNDA for rucaparib in the ovarian cancer maintenance setting just four months after we reported topline results marks an important milestone that brings Clovis closer to our ultimate goal of making rucaparib available to a broader population of women with advanced ovarian cancer,” Patrick J. Mahaffy, president and CEO of Clovis, said in a press release. The company's FDA application builds on data from the Phase 3 ARIEL3 trial (NCT01968213), which included 564 women with high-grade ovarian, fallopian tube or primary peritoneal cancer who had at least a partial response to platinum chemotherapy. The data — first revealed in June and then presented in its entirety at last month's European Society for Medical Oncology (ESMO) 2017 Congress in Madrid — showed that Rubraca he
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