Another PARP Inhibitor Gains FDA Approval to Expand First-Line Maintenance Therapy for Ovarian Cancer Patients

On May 8 local time, AstraZeneca and MSD jointly announced that the U.S. Food and Drug Administration (FDA) had approved the combination of their co-developed PARP inhibitor olaparib (Lynparza) with bevacizumab as a first-line maintenance therapy for ovarian cancer patients who achieved complete or partial response after platinum-based chemotherapy. These patients’ tumors are homologous recombination deficiency-positive (HRD+), defined by the presence of harmful BRCA gene mutations and genomic instability. Recently, the FDA also approved GlaxoSmithKline’s PARP inhibitor niraparib (Zejula) as first-line maintenance treatment for adult patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who achieved complete or partial response after first-line platinum-based chemotherapy.

The FDA’s approval was based on the clinical results from the Phase 3 PAOLA-1 trial, which included 387 patients with HDR-positive tumors. The results showed that olaparib combined with bevacizumab reduced the risk of disease progression or death by 67% (HR=0.33, 95% CI: 0.25–0.45). The median progression-free survival (PFS) in the olaparib plus bevacizumab combination therapy group was 37.2 months, compared to 17.7 months in the control group.

Currently, the European Union, Japan, and other countries are conducting regulatory reviews of olaparib in combination with bevacizumab as first-line maintenance therapy for patients with advanced ovarian cancer.

Responsible Editor: Squirtle

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