FDA approves Zejula sNDA for wider use in ovarian cancer

The US Food and Drug Administration has approved the supplemental New Drug Application (sNDA) for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, submitted by UK pharma major GlaxoSmithKline (LSE: GSK)

Zejula is now cleared as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status.

Until now, only 20% of women with ovarian cancer, those with a BRCA mutation (BRCAm), were eligible to be treated with a PARP inhibitor as monotherapy in the first-line maintenance setting.