FDA Approves GSK's Zejula for Ovarian Cancer Maintenance Therapy

The U.S. Food and Drug Administration (FDA) has approved GSK plc's Zejula (niraparib) as a first-line maintenance therapy for women with advanced ovarian cancer who have responded to initial platinum-based chemotherapy. This approval makes Zejula the only once-daily PARP inhibitor available for patients regardless of biomarker status, potentially expanding treatment options for approximately 80% of ovarian cancer patients who do not have a BRCA mutation.

The expanded indication is based on results from the PRIMA study, which demonstrated a significant improvement in progression-free survival (PFS) for patients treated with Zejula compared to placebo. The study showed benefits across all biomarker subgroups, including those whose tumors were homologous recombination proficient.

Zejula is administered orally once daily. The treatment regimen utilizes an individualized starting dose based on a patient's baseline weight and platelet count. An exploratory analysis indicated that this individualized dosing approach was associated with lower rates of Grade 3 and 4 hematologic treatment-emergent adverse events compared to the overall study population.

Ovarian cancer is a significant cause of cancer death among women in the U.S., with a high recurrence rate after initial treatment. This approval provides a new maintenance treatment option that aims to extend the time before disease progression for a broader group of patients.