FDA approves Zejula for first-line ovarian cancer maintenance
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The FDA approved niraparib for first-line maintenance treatment of certain women with advanced epithelial ovarian, fallopian tube or primary peritoneal cancers.
The approval applies to use of niraparib (Zejula, GlaxoSmithKline) — a poly(ADP-ribose) polymerase (PARP) inhibitor — by women who achieved complete or partial response to first-line platinum-based chemotherapy.
The FDA based the approval on results of the randomized phase 3 PRIMA trial, which included 733 women in complete or partial response to first-line platinum-based chemotherapy.
Researchers assigned the women to maintenance therapy with niraparib or placebo.
PFS — both in the homologous recombination deficient population and the overall study population — served as the main efficacy outcome.
Investigators reported statistically significant improvement in PFS among niraparib-treated women in both the homologous recombination deficient group (21.9 months vs. 10.4 months; HR = 0.43; 95% CI, 0.31-0.59) and the overall cohort (13.8 months vs. 8.2 months; HR = 0.62; 95% CI, 0.5-0.76).
The most common adverse events reported among niraparib-treated patients included thrombocytopenia, anemia, nausea, fatigue, neutropenia, constipation, musculoskeletal pain, leukopenia, headache, insomnia, vomiting, dyspnea, decreased appetite, dizziness, cough, hypertension, increased alanine aminotransferase and aspartate aminotransferase levels, and acute kidney injury.
The FDA previously granted priority review to niraparib for this indication.