Zejula application granted Fast Track, Priority Review.
The FDA recently approved Zejula (niraparib) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. Granted under Fast-Track, Priority Review and deemed a Breakthrough Therapy, Zejula is indicated for patients whose tumors have completely or partially shrunk (complete or partial response, respectively) in response to platinum-based chemotherapy.
Epithelial ovarian, fallopian tube and primary peritoneal cancers are cancers of the tissue covering the ovaries, the lining of the fallopian tubes or the abdominal wall. 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.
“Maintenance therapy is an important part of a cancer treatment regimen for patients who have responded positively to a primary treatment,” said Richard Pazdur, 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.”
A poly ADP-ribose polymerase (PARP) inhibitor, Zejula also received Orphan Drug designation from the FDA — specifically for its use in treating recurrent epithelial ovarian cancer. According to the FDA the designation provides incentives to assist and encourage the development of drugs that treat rare diseases. Zejula works by blocking an enzyme involved in repairing damaged DNA. By blocking this enzyme, the DNA inside cancerous cells may be less likely to be repaired, leading to cell death and possibly a slow-down or stoppage of tumor growth.