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FDA Approval Sought for Maintenance Rucaparib in Ovarian Cancer

Jason M. Broderick @jasoncology
Published: Tuesday, Oct 10, 2017

Patrick J. Mahaffy

Patrick J. Mahaffy
A supplemental new drug application (sNDA) has been submitted to the FDA for rucaparib (Rubraca) as maintenance treatment for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, according to Clovis Oncology, the manufacturer of the PARP inhibitor.

The sNDA is based on findings from the phase III ARIEL3 trial, in which maintenance rucaparib improved median progression-free survival (PFS) by 11.2 months compared with placebo for patients with BRCA-mutant platinum-sensitive ovarian cancer.
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