European regulators have cleared Tesaro’s Zejula, offering a new option for the maintenance treatment of certain adults with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
The approval allows for the drug’s use in patients who are in a complete response (CR) or partial response (PR) to platinum-based chemotherapy.
Zejula (niraparib) is the first once-daily, oral poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor to be approved in Europe for patients regardless of BRCA mutation status.
Around 45,000 women in Europe are diagnosed with ovarian cancer every year. 45,000 women diagnosed every year; in the EU, it is the sixth-most common cancer among women.
Platinum-based chemotherapy is an effective but its efficacy diminishes over time, and progression-free survival becomes shorter after each successive platinum treatment, highlighting the need for new treatment options.
According to Tesaro, Zejula provides an opportunity to increase progression-free survival after platinum therapy, which it says will have "a profound impact" on women and their families.
In clinical trials, the treatment was shown to cut the risk of disease progression or death by 73 percent in patients with germline BRCA mutations and by 55 percent in those without germline BRCA mutations, the firm noted.
“With the introduction of Zejula, treatment of women with recurrent ovarian cancer will improve markedly,” said Professor Dr Andreas Du Bois, Center Director of Gynecology & Gynecologic Oncology, Kliniken Essen-Mitte (Germany) and co-founder and past chair of the European Network of Gynecological Oncological Trial Groups (ENGOT).
“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.”