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AstraZeneca Reports Inclusion of Overall Survival Data in Labelling of Imfinzi (durvalumab) in the US

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AstraZeneca Reports Inclusion of Overall Survival Data in Labelling of Imfinzi (durvalumab) in the US

Shots:

  • The US FDA has approved the inclusion of OS data based on P-III PACIFIC study results in an update to the Imfinzi (durvalumab) US prescribing information for patients with unresectable- Stage III NSCLC prior not treated with platinum-based CT and radiation therapy (CRT)
  • The P-III study results demonstrated OS benefit by reducing the risk of death by 32% following 3yrs. post-hoc OS analysis showing 31% reduction in risk of death and 57% are still alive patients vs 44% with PBO
  • Imfinzi is a mAb targeting PD-L1- blocking its interaction with PD-1 and CD80 to counter the tumor's immune-evading tactics and is an approved therapy in 45+ countries including the US- EU and Japan

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Ref: AstraZeneca | Image: AstraZeneca


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