AstraZeneca’s (AZN) Imfinzi in combination with chemotherapy has been approved in the European Union, EU, for the treatment of adults with resectable non-small cell lung cancer, NSCLC, at high risk of recurrence and no epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements. In this regimen, patients are treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery. The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the pivotal AEGEAN trial, which were published in The New England Journal of Medicine. Approval is based on AEGEAN Phase III trial results which showed a 32% reduction in the risk of recurrence, progression or death vs. neoadjuvant chemotherapy alone
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