Forum Topic Regulatory Affairs
  • Conversation: AstraZeneca's Imfinzi wins FDA approval for lung cancer treatment

    • February 20, 2018 9:32 AM GMT
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      AstraZeneca's Imfinzi wins FDA approval for lung cancer treatment

      AstraZeneca's immunotherapy Imfinzi (durvalumab) has secured approval from the US Food and Drug Administration (FDA) for unresectable stage III non-small cell lung cancer (NSCLC).
      The approval is for the expanded use of Imfinzi to treat NSCLC patients whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT).
      Imfinzi, which is a human monoclonal antibody, functions by targeting the PD-1/PD-L1 pathway. The drug blocks the interaction of PD-L1 with PD-1 and CD80 proteins, thereby working against the immune-evading tactics of the tumor and releasing the inhibition of immune responses.
      AstraZeneca executive vice president and oncology business unit head Dave Fredrickson said: “The approval of Imfinzi in this earlier stage of non-small cell lung cancer is a truly meaningful milestone for patients who, until now, had no FDA-approved treatment options following chemoradiation therapy.
      Read more: http://bit.ly/2HuuNQs

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