FDA Grants Priority Review to Niraparib for Late-Stage Ovarian Cancer

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.

Stay up to date on the latest news in specialty pharmacy by getting Specialty Pharmacy Times in your mailbox or inbox for free!

Click here to sign up for free for the bi-monthly Specialty Pharmacy Times print journal delivered to your address.

Click here to sign up for our email newsletters delivered every Monday, Wednesday, and Friday, in addition to breaking news alerts.

Click here to follow us on Facebook. 

Click here to follow us on Twitter. 

Click here to join our LinkedIn group. 

Related Articles

A novel potential biomarker test could identify patients who would benefit from more advanced lung cancer screening.
In addition to a natural variation in genetic makeup, approximately 1 in 1000 people inherit a damaged or mutated copy of the BRCA1 gene from a parent.
Top news of the day from across the health care landscape.
Company Profile >
Industry Guide >
Market News >
Peer Exchange >
Conferences >
Subscribe >
Specialty Times Resources
About Us
Contact Us
Terms & Conditions
MJH Associates >
Pharmacy Times
American Journal of Managed Care
MD Magazine
Targeted Oncology
Physicians' Education Resource
Pharmacy & Healthcare Communications, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747

Copyright Specialty Pharmacy Times 2006-2019
Pharmacy & Healthcare Communications, LLC. All Rights Reserved.