Updates in US Food and Drug Administration approvals for poly-ADP-ribose polymerase inhibitors in Ovarian Cancer: A society of gynecologic oncology clinical practice review.

This Society of Gynecologic Oncology review synthesizes updated data from pivotal trials of poly-ADP-ribose polymerase inhibitors (PARPi) in ovarian cancer. Multiple phase III trials established PARPi as effective maintenance therapy, demonstrating substantial progression-free survival across biomarker-defined subgroups, particularly for patients with BRCA-mutated and homologous recombination-deficient (HRD) ovarian cancer. However, mature overall survival analyses and safety signals prompted the US Food and Drug Administration to narrow indications, while the broader indications were maintained by the European Medicines Agency. We review the current FDA approvals that now prioritize patients with BRCA-mutated and HRD ovarian cancers, underscoring the importance of biomarker stratification and careful patient selection. We discuss the evolving regulatory landscape and potential mechanisms of PARPi resistance.