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AstraZeneca and Merck's Lynparza (olaparib) Receives FDA's Approval for 1L BRCA-Mutated Advanced Ovarian Cancer

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AstraZeneca and Merck's Lynparza (olaparib) Receives FDA's Approval for 1L BRCA-Mutated Advanced Ovarian Cancer

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  • The approval is based on P-III SOLO-1 trial assessing Lynparza (300 mg bid) as maintenance monothx vs PBO in 391 patients in ratio (2:1) with BRCAm advanced ovarian cancer following first-line Pt-based CT for two years
  • P-III SOLO-1 trial results: reduction in risk of death 70%- patients remained progression free for three years- with safe and well-tolerated
  • Lynparza (olaparib) is PARP inhibitor- targeted for DNA damage response (DDR) pathway deficiencies- including BRCA mutations. In 2017- Merck and AZ collaborated to co-develop and co-commercialize Lynparza globally

Ref: Merck | Image: AstraZeneca 


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