Tesaro, Inc., has completed the niraparib rolling new drug application (NDA) submission to the FDA for the maintenance treatment of patients with platinum-sensitive, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to platinum-based chemotherapy.
The niraparib NDA was supported by data from the ENGOT-OV16/NOVA trial, a phase 3, international, double-blind, placebo-controlled study that enrolled 553 patients with recurrent ovarian cancer who were in response to their most recent platinum-based chemotherapy. The study was designed to assess progression-free survival (PFS) in patients who were assigned to one of two cohorts based on germline BRCA mutation status.
The study successfully achieved its primary endpoint in both patient cohorts, demonstrating that niraparib treatment significantly prolonged PFS compared with control. Based on the results of this study, the indication proposed in the niraparib NDA provides for use of the drug regardless of the patient’s tumor biomarker status.
Niraparib is an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor that is being evaluated in three pivotal trials. The ongoing development program for niraparib includes a phase 3 study in patients with first-line ovarian cancer (the PRIMA trial); a registrational phase 2 treatment trial in patients with ovarian cancer (the QUADRA trial); and a phase 3 study in patients with germline BRCA-mutated, metastatic breast cancer (the BRAVO trial). Several combination studies are also underway, including trials of niraparib plus pembrolizumab or niraparib plus bevacizumab.
In September, the FDA granted fast-track status to niraparib. This designation is designed to facilitate the development and expedite the review of medications that are intended to treat serious conditions and address unmet medical needs.
Approximately 22,000 women are diagnosed each year with ovarian cancer in the United States. Ovarian cancer is the fifth most frequent cause of cancer death among women. Despite high response rates to platinum-based chemotherapy in the second-line advanced treatment setting, approximately 85% of patients will experience recurrence within two years. If approved, niraparib may address the difficult “watchful waiting” periods experienced by patients with recurrent ovarian cancer in between cycles of platinum-based chemotherapy, according to Tesaro.
Source: Tesaro; November 1, 2016.