FDA Approves Neoadjuvant/Adjuvant Imfinzi for Resectable NSCLC

The FDA has approved durvalumab (Imfinzi, AstraZeneca) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors ≥4 cm and/or node-positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

Efficacy was evaluated in AEGEAN (ClinicalTrials.gov. Identifier: NCT03800134), a randomized,