Posted by Michael Wonder on 21 Dec 2016
Tesaro announces priority review designation for niraparib NDA
20 December 2016 - Niraparib new drug application accepted for review by FDA with a PDUFA goal date of 30 June 2017.
Tesaro today announced that the U.S. FDA has granted Priority Review for the niraparib new drug 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.
The FDA has established a target action date under the Prescription Drug User Fee Act of 30 June 2017, and is not currently planning to hold an advisory committee meeting to discuss this application.
