GSK’s Zejula (niraparib) Receives the US FDA’s Approval as 1L Monotherapy Maintenance Treatment for Women with Advanced Ovarian Cancer Regardless of Biomarker Status

 GSK’s Zejula (niraparib) Receives the US FDA’s Approval as 1L Monotherapy Maintenance Treatment for Women with Advanced Ovarian Cancer Regardless of Biomarker Status

GSK’s Zejula (niraparib) Receives the US FDA’s Approval as 1L Monotherapy Maintenance Treatment for Women with Advanced Ovarian Cancer Regardless of Biomarker Status

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

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

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

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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