FDA Approves Zejula For Maintenance Treatment in Advanced Epithelial Ovarian Cancer

The Food and Drug Administration (FDA) approved Zejula (niraparib) for the frontline maintenance treatment in adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.

The agency based its approval off results of the PRIMA study, a double-blind, placebo-controlled trial in which 733 patients, who were either in a complete or partial response from first-line chemotherapy, received either Zejula or placebo.

Progression-free survival (PFS) within the overall study population compared to the homologous recombination deficient population served as the main outcome of the study. Homologous recombination deficiency status was defined by the researchers as patients with the presence of the tBRCA gene or a genomic instability score of greater than or equal to 42. Patients with ovarian cancer who have this deficiency are often linked to improved responses to treatments that included PARP inhibitors like Zejula.

In both groups of patients, the researchers found a statistically significant improvement of PFS for patients who received Zejula compared to placebo. Patients with a homologous recombination deficiency had a PFS of 21.9 months compared to 10.4 months on placebo. In the overall population, PFS in patients who received Zejula was 13.8 months compared to 8.2 months in those who received placebo.

According to Axel Hoos, senior vice president and head of oncology at GlaxoSmithKline (the manufacturer of Zejula), this approval marks a simplification of the treatment paradigm. “Particularly now, in the COVID-19 environment where it’s harder for patients to go to the doctor and harder to receive an infusion or even do surgery—you just take a pill, and on top of that you don’t need to undergo testing to find out if you are eligible for this based on mutation. Everyone can benefit,” he said in a press release.

The most common side effects in patients who received the study drug was 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.

The recommended dose for Zejula as a maintenance treatment is dependent on a patient’s body weight and platelet count. For patients weighing less than 170 pounds, or with a platelet count of less than 150,000/μL, the recommended dose is 200 milligrams (mg) taken orally once daily, whereas, in patients above either of these limits, the recommended dose is 300 mg taken orally once daily.

Check back later for what you need to know about this approval.