The European Commission (EC) has granted marketing authorisation for US-based biopharmaceutical company Tesaro’s Zejula (niraparib) to treat women with recurrent ovarian cancer.
Zejula is the first once-daily, oral poly (ADP-ribose) polymerase (PARP) 1 / 2 inhibitor approved for use in Europe that does not require breast cancer (BRCA) mutation or other biomarker testing.
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The drug has been granted marketing rights 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 (CR) or partial response (PR) to platinum-based chemotherapy.
The current EC approval was based on data obtained from the clinically rigorous, double-blind, placebo-controlled, international Phase III ENGOT-OV16 / NOVA trial of niraparib.
The trial involved 553 patients with recurrent ovarian cancer who had achieved either a PR or CR to their most recent platinum-based chemotherapy.
The primary endpoint of the study was progression-free survival (PFS).
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By GlobalDataEuropean Network of Gynaecological Oncological Trial Groups (ENGOT) co-founder and past chair and Gynaecology & Gynaecologic Oncology, Kliniken Essen-Mitte (Germany) centre director Dr Andreas Du Bois said: “With the introduction of Zejula, treatment of women with recurrent ovarian cancer will improve markedly.
“Patients and their physicians are now empowered with an additional option to utilise after a response to chemotherapy, regardless of BRCA mutation status, where the previous alternative for most was a period of watching and waiting instead of actively controlling their disease.”
The approved starting dose of the therapy is currently 300mg per day.
On 27 March this year, Tesaro received approval for Zejula from the US Food and Drug Administration (FDA).
In December, the company intends to launch the treatment in Germany and the UK, with roll out in additional European countries expected to follow starting in 2018.
