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

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