3rd Mar 2025 11:13
(Alliance News) - AstraZeneca PLC on Monday said its lung cancer drug Imfinzi has been recommended for approval in the EU.
The Cambridge, England-based pharmaceuticals firm said Imfinzi, or durvalumab, in combination with chemotherapy, has been recommended for approval for the treatment of adults with resectable non-small cell lung cancer.
The recommendation was made by the Committee for Medicinal Products for Human Use, which is part of the European Medicines Agency, and was based on results from the Aegean phase three trial.
In the trial, the drug showed a "statistically significant and clinically meaningful" 32% reduction in the risk of recurrence, progression events or death versus neoadjuvant chemotherapy alone.
AstraZeneca Executive Vice President Susan Galbraith said: "This recommendation highlights the potential of Imfinzi to address an unmet need for patients with resectable lung cancer who need new treatment options that increase the time they live without recurrence or progression. Aegean underscores our commitment to transforming care in the early stages of lung cancer where there is the greatest potential for cure."
Imfinzi is approved in the US and "several other countries" based on the Aegean results. There are regulatory applications under review in China, Japan and other countries, AstraZeneca said.
Shares in AstraZeneca were down 0.2% at 11,946.00 pence in London on Monday morning.
By Michael Hennessey, Alliance News reporter
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