Tesaro Receives FDA Fast Track Designation for Niraparib and Initiates Rolling NDA Submission

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"The initiation of this rolling NDA submission is a significant milestone for Tesaro, and we are committed to working collaboratively with the FDA to advance the review of the niraparib application," said Mary Lynne Hedley, Ph.D., President and COO of Tesaro. "We look forward to presentation of data from the Phase 3 NOVA trial of niraparib in a Presidential Symposium session at the European Society for Medical Oncology (ESMO) congress on October 8."
NOVA is a double-blind, placebo-controlled, international Phase 3 trial of niraparib that enrolled more than 500 patients with recurrent ovarian cancer who were in a response to their most recent platinum-based chemotherapy.