GSK Reports the Acceptance of EMA’s MAA for Zejula (niraparib) as 1L Maintenance Treatment for Platinum-Responsive Advanced Ovarian Cancer

GSK Reports Acceptance of EMA’s MAA for Zejula (niraparib) as 1L Maintenance Treatment for Platinum-Responsive Advanced Ovarian Cancer

Shots:

  • The EMA has accepted Type II Variation (T2V) for Zejula as maintenance therapy in a 1L setting for women with advanced platinum-responsive advanced OC, regardless of biomarker status. The validation indicates the acceptance of MAA and the initiation of CHMP’s formal review process
  • The submission is based on P-III PRIMA study assessing Zejula vs PBO in women in a ratio (2:1) as 1L therapy for stage III/ IV platinum-responsive advanced OC. The study demonstrated clinical outcomes of Zejula
  • Zejula (PO, qd) is a PARP inhibitor, indicated as a monothx. for the maintenance treatment of patients with platinum‑sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to platinum-based CT

Click here ­to­ read full press release/ article | Ref: GSK | Image: StraitTimes