Officials with the FDA have granted priority review to a supplemental New Drug Application (sNDA) for niraparib (Zejula) for the treatment of certain patients with advanced ovarian, fallopian tube, or primary peritoneal cancer, according to a press release.
Niraparib is an oral, once-daily poly (ADP-ribose) polymerase inhibitor that is currently being evaluated in 3 clinical trials.
The sNDA, which was submitted by Tesaro, supports the expanded indication to include patients who have been treated with 3 or more prior chemotherapy regimens and whose cancer is associated with either BRCA mutation or homologous recombination deficiency (HRD) and who have progressed more than 6 months after the last platinum-based chemotherapy.
Ovarian cancer is the fifth most frequent cause of cancer death among women, according to GlaxoSmithKline. Approximately 85% of patients will experience disease recurrence within 2 years of treatment with platinum-based chemotherapy, indicating the need for more late-line treatment options.
Submission of the application is based on data from the phase 2 QUADRA study that evaluated the safety and activity of niraparib in previously-treated adults with relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
For the study, 463 patients received oral niraparib 300 mg once daily continuously until disease progression. Patients had a median of 4 previous lines of therapy and the median follow-up for overall survival was 12.2 months, according to the data. Thirty-three percent of the patients were resistant and 35% were refractory to the last administered platinum therapy. Overall, 28% of 47 patients in the primary efficacy population achieved an overall response.
The most common grade 3 or worse treatment-emergent adverse effects (AEs) were anemia and thrombocytopenia and the most common treatment-emergent serious AEs were small intestinal obstruction, thrombocytopenia, and vomiting.
“The results of the QUADRA study demonstrate that Zejula is active as a late-line treatment for patients beyond those with BRCA mutations,” Mary Lynne Hedley, PhD, president and chief operating officer of Tesaro, said in a statement. “With this study, we continue to advance our mission to provide more patients with ovarian cancer an opportunity to benefit from treatment with Zejula.”
The application has an estimated action date of October 24, 2019, according to the release.
Other clinical trials are underway to evaluate niraparib in combination with other therapies, including pembrolizumab in the TOPACIO trial and bevacizumab in the ENGOT/OV24/AVANOVA trial.
US Food and Drug Administration accepts GSK’s application for Zejula (niraparib) in late stage ovarian cancer with priority review [news release]. GlaxoSmithKline. https://www.gsk.com/en-gb/media/press-releases/us-food-and-drug-administration-accepts-gsk-s-application-for-zejula-niraparib-in-late-stage-ovarian-cancer-with-priority-review/
. Accessed June 24, 2019.