The European Commission Approves Treatment for Recurrent Ovarian Cancer

The European Commission has granted marketing authorization for TESARO, Inc.’s  ZEJULA drug. The once-daily oral drug is for the maintenance treatment of adult patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. The approved starting dose of the drug is 300 milligrams once per day. 

This comes after ZEJULA’s FDA approval in March. It is currently the most frequently prescribed PARP inhibitor for patients with ovarian cancer in the United States. TESARO plans to launch the drug in Germany and the UK this December, with launches in additional European countries to follow beginning in 2018, based on local reimbursement and availability timelines. 

“Today’s approval of ZEJULA is an exciting step forward for the ovarian cancer community in Europe. While platinum-based chemotherapy has proven to be effective, its efficacy unfortunately diminishes over time, and progression-free survival becomes shorter after each successive platinum treatment,” said Mansoor Raza Mirza, M.D., ENGOT-OV16/NOVA Study chair and chief oncologist at Rigshospitalet, Copenhagen. “ZEJULA now provides an opportunity to increase progression-free survival after platinum therapy, and will have a profound impact for women and their families.”

The EC approval was based on data from the clinically rigorous ENGOT-OV16/NOVA trial, a double-blind, placebo-controlled, international Phase 3 study of ZEJULA.