FDA Approves GSK’s Zejula for Recurrent Ovarian Cancer

GlaxoSmithKline received the FDA’s approval for Zejula (niraparib) as a late-line treatment for women with recurrent ovarian cancer.

The drug’s new indication is based on the results of a phase 2, multi-center, open-label, single-arm clinical trial that showed an objective response rate of 24 percent and a median duration of response of 8.3 months.

The approval makes the drug the only once-daily PARP inhibitor approved as a monotherapy treatment for recurrent ovarian cancer beyond those with a BRCA mutation in both the recurrent maintenance and late-line treatment settings.