Posted by Michael Wonder on 12 Sep 2016
Tesaro receives FDA fast track designation for niraparib and initiates rolling NDA submission
12 September 2016 - Tesaro today announced that the U.S. FDA has granted fast track designation to niraparib for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.
Tesaro has initiated a rolling submission of a new drug application for niraparib to the FDA, and intends to complete this submission during the fourth quarter.
The marketing authorisation application for niraparib is planned for submission to the EMA in the fourth quarter.
