The European Commission (EC) has granted marketing authorisation for 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 PARP 1/2 inhibitor to be approved in Europe that does not require BRCA mutation or other biomarker testing.

This follows the Committee for Medicinal Products for Human Use (CHMP) issuing 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.

“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,” said Mansoor Raza Mirza, M.D., ENGOT-OV16/NOVA Study Chair and Chief Oncologist at Rigshospitalet, Copenhagen. “Niraparib now provides an opportunity to increase progression-free survival after platinum therapy, and will have a positive impact for women and their families.”

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.

The primary endpoint of the trial was progression free survival (PFS).

Approximately two-thirds of study participants did not have germline BRCA mutations.

Progression in the NOVA study was determined by robust, unbiased, blinded central review to be the earlier of radiographic or clinical progression.

Niraparib significantly increased PFS in patients with and without germline BRCA mutations as compared to the control arm (p<0.001 in both populations).

Treatment with niraparib reduced the risk of disease progression or death by 73% in patients with germline BRCA mutations (HR 0.27) and by 55% in patients without germline BRCA mutations (HR 0.45).

The magnitude of benefit was similar for patients entering the trial with a PR or a CR.

“The approval of niraparib marks a vital step forward in the fight to improve the outcome of women with this aggressive form of advanced ovarian cancer,” said Professor Jonathan Ledermann, UCL Cancer Institute. “The increase we have seen in progression free survival with niraparib for women who have already undergone chemotherapy therapy is very encouraging. The fact that niraparib is also potentially a therapeutic option for women regardless of BRCA mutation status makes niraparib an important development and one that meets an urgent need in the UK. Our hope now is that women who can benefit from this medicine are able to access it as quickly as possible."

“We want to express our gratitude to all of the women who selflessly participated in the niraparib 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 rigor. 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, Ph.D., 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.”

Source: Reynolds Mackenzie