Shots:

• The approval is based on P-III PRIMA study assessing Zejula (300/200mg- qd) vs PBO in patients with newly diagnosed advanced ovarian cancer following complete or partial response to platinum-based CT regardless of biomarker status
• The P-III PRIMA study resulted in a 57% improvement in PFS in HRd population and a 38% reduction in the risk of disease progression in the overall population. The new individualized starting dose is based on the patient’s weight and/or platelet count; lower rates of hematological AEs were observed with the individualized dosing group
• Zejula (qd) is a PARP inhibitor- currently being evaluated in multiple pivotal studies and is an approved therapy in the US as monothx. for women with advanced OC beyond those with BRCAm disease in the 1L and recurrent maintenance treatment settings- as well as late-line primary treatment settings

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Ref: GSK | Image: GSK