Shots:

• The approval is based on PRIMA study assessing Zejula (300mg qd)- later amended to incorporate an individualised starting dose of Zejula (200 mg or 300 mg- qd) based on the patient’s baseline weight and/or platelet count
• Results: The PRIMA study improved PFS for patients treated with Zejula- regardless of biomarker status. In the HRd population- Zejula reduced the risk of disease progression or death vs. pbo by 57% and the risk of disease progression or death vs. pbo by 38% in the overall population. Additionally- risk of progression in those with BRCA mutation tumours showed 60% reduction
• Zejula is an oral- once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. It is the first PARP inhibitor approved as monotherapy in the EU for patients with platinum-responsive advanced ovarian cancer

  Ref: Gsk | Image: GSK