HealthDay News — The US Food and Drug Administration has approved Zejula (niraparib) to treat adult women with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers whose tumors have shrunk in response to platinum-based chemotherapy.
Zejula, a poly ADP-ribose polymerase (PARP) inhibitor, was evaluated in clinical studies involving 553 patients with any of these recurring cancers who had had their tumors shrunk by at least two doses of platinum-based chemotherapy.
The average progression-free survival of certain women given Zejula was 21 months, compared with 5.5 months among women who took a placebo, the FDA said.
The most common side effects were anemia, thrombocytopenia, neutropenia or leukopenia, heart palpitations, nausea, constipation, abdominal distention, and mucositis. More serious adverse reactions could include hypertension and myelodysplastic syndrome, the FDA said.
“Maintenance therapy is an important part of a cancer treatment regimen for patients who have responded positively to a primary treatment,” Richard Pazdur, MD, 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 in a statement.
“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.”
Approval of Zejula was granted to Tesaro.
FDA Approves Maintenance Treatment for Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancers [press release]. Silver Spring, MD: US Food and Drug Administration; March 27, 2017.