CHMP Favors Zejula as First-line Maintenance Therapy for Platinum-sensitive Advanced Ovarian Cancer

CHMP Favors Zejula as First-line Maintenance Therapy for Platinum-sensitive Advanced Ovarian Cancer
The Committee for Medicinal Products for Human Use (CHMP) has recommended Zejula (niraparib) as a first-line maintenance therapy for women with advanced ovarian cancer who responded to platinum-based chemotherapy. This favorable opinion by the committee, a branch of the European Medicines Agency (EMA), is one of the final steps of Zejula’s marketing authorization procedure that may lead to its approval by the European Commission. If approved, Zejula will be the first PARP inhibitor used as a first-line maintenance therapy for women with advanced platinum-responsive ovarian cancer, regardless of whether their tumors are defective in DNA repair. “Only 20% of women with ovarian cancer are currently eligible to be treated with a PARP inhibitor in the first-line maintenance setting,” Axel Hoos, MD, PhD, senior vice president and head of oncology research and development at GlaxoSmithKline (GSK), which is developing Zejula, said in a press release. “Today’s positive opinion from the CHMP will give all women in response to platinum-based chemotherapy the option to receive Zejula in the maintenance setting, reinforcing our belief in the important role this innovative medicine may play in helping these patients and the physicians working to treat them,” he added. The committee’s favorable recommendation was based on data from the PRIMA Phase 3 trial (ENGOTOV26/GOG-3012; NCT02655016), which is assessing the efficacy of Zejula maintenance therapy in women with newly diagnosed advanced ovarian cancer who responded to platinum-based chemo. Approximately half of the women enrolled in the study had tumors that contained mutations in the BRCA DNA repair genes. From the 733 women who enrolled in PRIMA, 487 were randomly assigned to receive Zejula and 2
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