20 November 2017 - Approval supported by robust data from a randomised, well-controlled Phase 3 trial.

Tesaro announced today that the European Commission has granted marketing authorisation for Zejula (niraparib) as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy. Zejula is the first once-daily, oral poly polymerase1/2 inhibitor to be approved in Europe that does not require BRCA mutation or other biomarker testing.

“We want to express our gratitude to all of the women who selflessly participated in the Zejula clinical development program. I would also like to thank our partners at ENGOT for their diligence in conducting the ENGOT-OV16/NOVA trial, which was carried out with the highest level of scientific rigour. The unique design of this trial, which included women both with and without germline BRCA mutations, allowed us to independently determine that ZEJULA provides significant progression-free survival improvement in a very broad patient population,” said Mary Lynne Hedley, Ph.D., President and Chief Operating Officer of Tesaro. “The EC approval of Zejula marks Tesaro’s second product approval in Europe this year. We are committed to working with healthcare providers, payers and patient groups to enable access to this paradigm-changing treatment as quickly as possible.”

Read Tesaro press release