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FDA grants fast track designation to niraparib for ovarian cancer
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The FDA granted fast track designation to niraparib for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube or primary peritoneal cancer, according to the drug’s manufacturer.
Niraparib is an oral, once-daily PARP inhibitor that is being evaluated in four ongoing clinical trials.
Data from the phase 3 NOVA trial — designed to evaluate niraparib (MK-4827, Tesaro) in more than 500 patients with recurrent ovarian cancer who were in a response to their most recent platinum-based chemotherapy — will be presented in October at the European Society for Medical Oncology Congress in Copenhagen, Denmark.
The agent also is under evaluation as a first-line treatment for ovarian cancer, as well as for the treatment of patients with BRCA–positive breast cancer. Other trials are evaluating niraparib in combination with pembrolizumab (Keytruda, Merck) and bevacizumab (Avastin, Genentech).
Tesaro initiated a rolling submission of a new drug application for niraparib to the FDA, and the submission should be complete by the fourth quarter of this year, according to a company-issued press release.
“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,” Mary Lynne Hedley, PhD, president and chief operation officer of TESARO, said in the press release.