Tesaro secures EU approval in specific ovarian cancer population

The European Commission has granted Tesaro’s Zejula (niraparib) marketing approval in Europe, it has emerged.  Zejula is a poly (ADP-ribose) polymerase (PARP)1/2 inhibitor and is indicated as a monotherapy for maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. The drug does not require BRCA mutation or other biomarker testing.

The EC’s decision was based on trial data collected from 553 patients with the condition, which included 32 patients tested in the UK across nine sites in partnership with the National Cancer Research Institute. Of this total number, around two-thirds did not have germline BRCA mutations.

The data demonstrated that Zejula significantly increased progression-free survival rates in patients both with and without germline BRCA mutations, with patients benefiting to a similar degree whether they entered the trial with a complete or partial response.

 "The unique design of this trial, which included women both with and without germline BRCA mutations, allowed us to independently determine that niraparib provides significant progression-free survival improvement in a very broad patient population," said Mary Lynne Hedley, President and Chief Operating Officer of Tesaro. "The EC approval of niraparib 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 important new treatment as quickly as possible."

Dr Mansoor Raza Mirza, Study Chair of the UK-based ENGOT-OV16/NOVA trial and Chief Oncologist at Rigshospitalet, Copenhagen, added: "Today’s approval of niraparib 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. Niraparib now provides an opportunity to increase progression-free survival after platinum therapy, and will have a positive impact for women and their families."