Since the first global approval of niraparib in the US, the agent has now been approved in Europe. The US approval has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs, based on the development milestones tracked in AdisInsight.
In November, 2017, niraparib (Zejula™), developed by Tesaro Inc., was approved in the EU plus Liechtenstein, Iceland, and Norway as 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 or partial response to platinum-based chemotherapy.
Both the US and the European approvals were based on the positive results from the 553 patients who completed the phase III NOVA study.
Mansoor Raza Mirza, MD, the NOVA study Chair and Chief Oncologist at Rigshospitalet, Copenhagen described the latest approval of niraparib as “an exciting step forward for the ovarian cancer community in Europe.” This, he explained, was because, “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, ZEJULA now provides an opportunity to increase progression-free survival after platinum therapy, and will have a profound impact for women and their families.” 
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