Proactive Investors - AstraZeneca PLC's (LON:AZN) blockbuster immunotherapy-based cancer drug Imfinzi (durvalumab) has received another approval in the US.
In combination with chemotherapy, patients suffering resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) can now receive Imfinzi before and after surgery.
AstraZeneca (NASDAQ:AZN) added that the approval by the US Food and Drug Administration (FDA) was based on positive results from the AEGEAN trial, which were published in The New England Journal of Medicine in October 2023.
John V. Heymach, Professor and Chair Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, said: "This approval brings an important new treatment option that should become a backbone combination approach for patients with resectable non-small cell lung cancer, who have historically faced high rates of recurrence even after chemotherapy and surgery".
Dave Fredrickson, executive vice president, Oncology Business Unit, AstraZeneca, said: "Today's approval of Imfinzi in resectable early-stage lung cancer builds on its strong foundation of changing clinical practice in unresectable Stage III disease.
“We remain committed to bringing novel approaches like AEGEAN to early lung cancer settings where cure is the goal of treatment."
Imfinzi has also been approved in the UK, Switzerland, and Taiwan (China) in this setting based on the AEGEAN results.
Regulatory applications are currently under review in the EU, China and several other countries in this indication.