FDA Approves Zejula for Maintenance Treatment of Cancer

The FDA has approved Tesaro’s Zejula (niraparib) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. The drug is indicated for patients whose tumors have completely or partially shrunk in response to platinum-based chemotherapy.

The approval is based on data from a clinical trial which supports the safety and efficacy of Zejula. The trial included 553 patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who had received at least 2 prior treatments of platinum-based chemotherapy and who had experienced a complete or partial response to their most recent chemotherapy treatment.

The median progression-free survival for patients taking the drug who had a germline BRCA mutation was 21 months compared with 5.5 months in patients taking a placebo. In patients who did not have a germline BRCA mutation, median progression-free survival was 9.3 months compared with 3.9 months in patients in the placebo group.

Adverse effects of Zejula include anemia, thrombocytopenia, neutropenia or leukopenia, heart palpitations, nausea, constipation, vomiting, distention, diarrhea, mucositis, indigestion, dry mouth, fatigue, decreased appetite, urinary tract infection, AST/ALT elevation, myalgia, back pain, arthralgia, headache, dizziness, dysgeusia, insomnia, anxiety, nasopharyngitis, dyspnea, cough, rash, and hypertension.

Reference

FDA approves maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm548948.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Published Mar. 27, 2017.