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FDA Approves Niraparib as Maintenance Therapy for Advanced Ovarian Cancer
On April 29, 2020, the FDA approved niraparib (Zejula; GlaxoSmithKline) for use as maintenance therapy in adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer that completely or partially responded to first-line platinum-based chemotherapy. The application for this drug was granted priority review by the FDA.
This approval was based on efficacy evaluated in the double-blind, placebo-controlled PRIMA clinical trial of 733 patients with complete or partial responses to first-line platinum-based chemotherapy. These patients were randomized to receive niraparib or matched placebo.
The main efficacy end point, progression-free survival (PFS), was evaluated first in the homologous recombination deficient population and then in the overall population. Investigators behind PRIMA tested tumor samples for homologous recombination deficiency status (defined as the presence of a tumor breast cancer susceptibility gene (tBRCA) mutation or genomic instability score ≥42).
Ultimately, patients randomized to receive niraparib versys placebo in the homologous recombination deficient and overall populations had statistically significant improvements in PFS.
In the homologous recombination deficient population, the median PFS was 21.9 months with niraparib versus 10.4 months with placebo (hazard ratio [HR], 0.43; 95% CI, 0.31-0.59; P <.0001).
In the overall population, the median PFS was 13.8 months versus 8.2 months, respectively (HR, 0.62; 95% CI, 0.50, 0.76; P <.0001).
The most common (≥10%) adverse reactions reported with niraparib in the PRIMA trial were thrombocytopenia, anemia, nausea, fatigue, neutropenia, constipation, musculoskeletal pain, leukopenia, headache, insomnia, vomiting, dyspnea, decreased appetite, dizziness, cough, hypertension, AST/ALT elevation, and acute kidney injury.—Hina Porcelli
Source: US Food and Drug Administration. FDA approves niraparib for first-line maintenance of advanced ovarian cancer. April 29, 2020. www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-niraparib-first-line-maintenance-advanced-ovarian-cancer. Accessed April 29, 2020.
