27 March 2017 - The U.S. FDA today approved Zejula (niraparib) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumours have completely or partially shrunk (complete or partial response, respectively) in response to platinum-based chemotherapy.

“Maintenance therapy is an important part of a cancer treatment regimen for patients who have responded positively to a primary treatment,” said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence. “Zejula offers patients a new treatment option that may help delay the future growth of these cancers, regardless of whether they have a specific genetic mutation.”

The FDA granted this application fast track, priority review and breakthrough therapy designations.

Zejula also received orphan drug designation specifically for its use in treating recurrent epithelial ovarian cancer. This designation provides incentives to assist and encourage the development of drugs for rare diseases.

Read FDA press release