FDA Advisory Committee reviewed Imfinzi for treatment of resectable non-small cell lung cancer based on AEGEAN Phase III trial results
The Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) acknowledged that AstraZeneca’s Imfinzi (durvalumab) met the primary endpoint of event-free survival (EFS) in the treatment of resectable non-small cell lung cancer (NSCLC) based on the AEGEAN Phase III trial results with an overall tolerable safety profile. In the trial, adult patients with resectable early-stage (IIA-IIIB) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements were treated with Imfinzi in combination with neoadjuvant