The FDA approved niraparib (Zejula) for the maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to frontline platinum-based chemotherapy.
By using the Real-Time Oncology Review (RTOTR), the FDA was able to approve the agent 2 months ahead of the goal date.
The approval was based off findings from the double-blind, placebo-controlled PRIMA trial (NCT02655016), which included 733 patients who were randomized to either niraprib or placebo.
Participants’ tumor samples were tested for homologous recombination deficiency status, defined by presence of tumor breast cancer susceptibility gene (tBRCA) mutation or genomic instability score (GIS) of 42 or higher. Progression-free survival (PFS) was first tested in the homologous recombination deficient population, then the overall population.
Patients given niraparib had a significant improvement in PFS compared to those on a placebo in both the recombination deficient and overall population. Median PFS in the homologous recombination deficient population was 21.9 months on the niraparib arm, compared to 10.4 months for those receiving placebo. Average PFS overall was 13.8 months and 8.2 months, for the niraparib and placebo arms, respectively.
It is recommended that niraparib dosage is based on body weight or platelet count. For patients under 170 pounds (77 kg) or with a platelet count less than 150,000/ μL, the recommended dose is 200 mg once per day, taken orally. For patients heavier than 170 pounds AND with platelet counts greater than or equal to 150,000/ μL, it is recommended that they take 300 mg once per day.
Common adverse events occurring in 10% or more of patients receiving niraparib 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.
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