EC approves ZEJULA for recurrent ovarian cancer

Amy Schofield 23 November 2017

The European Commission (EC) has granted marketing authorisation for TESARO's 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 response (complete or partial) to platinum-based chemotherapy.

Niraparib is the first once-daily, oral poly (ADP-ribose) polymerase (PARP)1/2 inhibitor to be approved in Europe that does not require BRCA mutation or other biomarker testing.

The EC approval of niraparib was based on data from the clinically rigorous ENGOT-OV16/NOVA trial, a double-blind, placebo-controlled, international Phase 3 study of niraparib that enrolled 553 patients with recurrent platinum sensitive ovarian cancer who had achieved either a PR or CR to their most recent platinum-based chemotherapy.

In the UK there were nine ENGOT-OV16/NOVA trial sites with 32 patients enrolled. The UK trials were conducted in partnership with the National Cancer Research Institute (NCRI). 
On the 15th September 2017, the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for the Marketing Authorisation Application for niraparib as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed ovarian cancer. 

Dr Mansoor Raza Mirza, ENGOT-OV16/NOVA Study Chair and Chief Oncologist at Rigshospitalet, Copenhagen, said: “Today’s approval of niraparib is an exciting step forward for the ovarian cancer community in Europe. Niraparib now provides an opportunity to increase progression-free survival after platinum therapy, and will have a positive impact for women and their families.”

Mary Lynne Hedley, Ph.D., President and Chief Operating Officer of TESARO, said: “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.”

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