Clovis to Apply for Expanded FDA Approval for Rubraca in Ovarian Cancer Patients

Clovis to Apply for Expanded FDA Approval for Rubraca in Ovarian Cancer Patients
Clovis Oncology plans to apply to the U.S. Food and Drug Administration (FDA) for expanded approval of Rubraca (rucaparib) as a second-line and later maintenance treatment for all women with ovarian cancer who have responded to their latest treatment with platinum chemotherapy. The decision came with the company's announcement of positive outcomes of a Phase 3 trial (NCT01968213) called ARIEL3. The study showed Rubraca improved progression-free survival in all patients regardless of the type of tumor mutations — which allowed the trial to meet its primary goal. “We are very pleased with these positive ARIEL3 topline results that strongly demonstrate the potential of rucaparib [Rubraca] to help women with platinum-sensitive, advanced ovarian cancer,” Patrick J. Mahaffy, president and CEO of Clovis Oncology, said in a press release. The study included women with ovarian cancer having mutations in the BRCA genes and patients who were homologous recombination deficiency (HRD)-positive, including patients with and without BRCA mutations. All women had been treated with, and responded to, platinum-based therapy before being randomized to receive either Rubraca or placebo in the trial. Analyses showed Rubraca improved progression-free survival in all patient groups. The findings were confirmed by a blinded, independent central review — an analysis that made up one of the trial’s secondary goals. "These results reinforce the potentially foundational role of rucaparib in the management of advanced ova
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