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An prominent player of Healthcare sector, AstraZeneca PLC has announced that its immunotherapy drug Imfinzi (durvalumab) has been granted an additional approval by the US Food and Drug Administration (FDA). The new approval allows Imfinzi to be used in combination with chemotherapy for patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC), both before and after surgery.
The FDA’s decision was influenced by positive outcomes from the AEGEAN trial, which were published in The New England Journal of Medicine in October 2023. The trial results demonstrated the effectiveness of Imfinzi in this setting, marking a significant development in the treatment of early-stage lung cancer.
Expert Commentary
John V. Heymach, Professor and Chair of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center, highlighted the importance of this approval. He noted that Imfinzi offers a crucial new treatment option for patients with resectable NSCLC, who historically face high rates of recurrence even after undergoing chemotherapy and surgery.
Dave Fredrickson, Executive Vice President of AstraZeneca PLC (LSE:AZN)’s Oncology Business Unit, emphasized that this approval enhances Imfinzi’s role in early-stage lung cancer treatment, building on its established efficacy in treating unresectable Stage III disease. He affirmed AstraZeneca’s dedication to advancing innovative treatments for early lung cancer, where the goal is to achieve a cure.
Global Status
In addition to the US approval, Imfinzi has already been authorized for use in the UK, Switzerland, and Taiwan (China) based on the AEGEAN trial results. The drug’s regulatory applications are currently under review in the European Union, China, and several other regions for this indication.
