FDA Grants Fast Track Status to Tesaro’s Niraparib for Ovarian, Other Cancers

FDA Grants Fast Track Status to Tesaro’s Niraparib for Ovarian, Other Cancers

Tesaro has received fast track designation from the U.S. Food and Drug Administration (FDA) for the use of niraparib in patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. The FDA’s fast track program will facilitate niraparib’s development and expedite review to address highly unmet medical needs.

As part of the fast track program, the FDA allows for the submission of completed portions of a new drug application (NDA), which proposes the FDA approve a new pharmaceutical for sale and marketing in the U.S. on an ongoing or rolling basis. Tesaro has already initiated an NDA rolling submission for niraparib and expects to complete the submission later this year.

Tesaro also intends to submit a marketing authorization application for niraparib to the European Medicines Agency in the fourth quarter of this year.

“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, Tesaro’s president and chief operating officer, said in a press release.

Niraparib is an oral PARP inhibitor that is being developed for tumors with mutations in proteins involved in DNA repair such as BRCA. By inhibiting PARP, which is also involved in the cell’s DNA repair mechanisms, niraparib induces a high number of errors in the tumor cell’s genetic material, ultimately resulting in cell death.

Currently, Tesaro is evaluating niraparib in four ongoing clinical trials, including the double-blind, placebo-controlled, international NOVA Phase 3 trial (NCT01847274), that is evaluating niraparib in ovarian cancer patients with BRCA mutations or high-grade tumors and who have responded to their most recent platinum-based chemotherapy (a type of chemotherapy that induces errors in the DNA).

The NOVA trial has enrolled more than 500 patients and recent data has shown that niraparib significantly prolonged the progression-free survival of patients with BRCA or other mutations in DNA repair genes compared to placebo.

Other trials for niraparib include the PRIMA Phase 3 trial (NCT02655016) for women with first-line ovarian cancer, the QUADRA Phase 2 trial (NCT02354586) for ovarian cancer patients who have received three or four previous chemotherapy regimens, and the BRAVO Phase 3 trial (NCT01905592) for patients with BRCA-positive breast cancer.

“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,” Hedley said.