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

 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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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