FDA approves new PARP ovarian cancer drug

US biotech firm Tesaro saw its shares gain 5.9% to $156.73 in after-hours trading on Monday after the US Food and Drug Administration announced approval for its new oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor intended for the treatment of ovarian cancer

Earlier than expected, the FDA cleared Zejula (niraparib) for marketing as a maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumors have completely or partially shrunk (complete or partial response, respectively) in response to platinum-based chemotherapy. The agency’s proposed action date was June 30.

Zejula is the first PARP inhibitor to be approved by the FDA that does not require BRCA mutation or other biomarker testing. However, the FDA has already approved PARP inhibitors from Clovis Oncology (Nasdaq: CLVS) and AstraZeneca (LSE: AZN), Rubraca (rucaparib) and Lynparza (olaparib) respectively, but those approvals were limited to patients with the BRCA mutation.