FDA to conduct ‘real-time’ review of Zejula for advanced ovarian cancer
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The FDA accepted a supplemental new drug application for niraparib as first-line maintenance treatment of women with platinum-responsive advanced ovarian cancer.
The agency will evaluate the application as part of its Real-Time Oncology Review pilot program, which is evaluating a more efficient process in hopes of maintaining review quality while ensuring effective and safe therapies are available to patients as soon as possible.
Niraparib (Zejula, GlaxoSmithKline) — a poly(ADP-ribose) polymerase (PARP) inhibitor — is approved in the United States as maintenance treatment for women with recurrent ovarian cancer who are in response to platinum-based chemotherapy regardless of BRCA mutations status. It also is approved to treat women with advanced ovarian cancer who received at least three prior chemotherapy regimens.
The supplemental application is based on data from the randomized phase 3 PRIMA study, which included women with stage III or stage IV ovarian cancer who were in complete or partial response to first-line platinum-based chemotherapy.
Researchers assigned the women 2:1 to maintenance therapy with niraparib or placebo. As Healio previously reported, results showed niraparib significantly extended median PFS in the overall study population (13.8 months vs. 8.2 months; HR = 0.62; 95% CI, 0.5-0.75) and among a subgroup of women with homologous recombination-deficient tumors (21.9 months vs. 10.4 months; HR = 0.43; 95% CI, 0.31-0.59).