The U.S. Food and Drug Administration today approved Zejula (niraparib) for the maintenance treatment (intended to delay cancer growth) 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 safety and efficacy of Zejula were studied in a randomized trial of 553 patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who had received at least two prior treatments of platinum-based chemotherapy and who had experienced a complete or partial response to their most recent chemotherapy treatment.
The U.S. FDA approves Tesaro's ovarian cancer drug, Niraparib.