FDA OK’s Tesaro’s ovarian cancer drug

The U.S. Food and Drug Administration has approved Tesaro’s Zejula (niraparib) for the maintenance treatment (intended to delay cancer growth) of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumors have completely or partially shrunk (complete or partial response, respectively) in response to platinum-based chemotherapy.

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 said that 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.

Epithelial ovarian, fallopian tube or primary peritoneal cancer is a cancer of the tissue covering the ovary or lining the fallopian tube or abdominal wall (peritoneum). The National Cancer Institute estimates that more than 22,000 women will be diagnosed with these cancers in 2017 and more than 14,000 will die of these diseases.

Zejula is a poly ADP-ribose polymerase (PARP) inhibitor that blocks an enzyme involved in repairing damaged DNA. By blocking this enzyme, DNA inside the cancerous cells may be less likely to be repaired, leading to cell death and possibly a slow-down or stoppage of tumor growth, the FDA explained.

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.