TESARO is up more than 2% after the company said the U.S. Food and Drug Administration (FDA) has granted Priority Review for the niraparib New Drug Application.
The FDA has established a target action date under the Prescription Drug User Fee Act (PDUFA) of June 30, and is not currently planning to hold an advisory committee meeting to discuss this application.
Niraparib is a PARP inhibitor that is being evaluated as a potential new treatment option for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer following response to platinum-based chemotherapy.
An Expanded Access Program (EAP) for niraparib in the United States is planned to open in January. Expanded access programs enable patients with serious or life-threatening illnesses who do not otherwise qualify for participation in a clinical trial and for whom there are no comparable or satisfactory alternate therapies to access investigational medicines. Through the program, niraparib will be made available for patients with recurrent ovarian cancer following response to platinum-based chemotherapy.