July 25, 2024 Meeting of the Oncologic Drugs Advisory Committee (ODAC)

The Committee will discuss supplemental biologics license application (sBLA) 761069/S-043, for IMFINZI (durvalumab) injection, submitted by AstraZeneca UK Limited. The proposed indication (use) is IMFINZI in combination with chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy after surgery, for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC). The Committee will also be asked to discuss whether drug sponsors should be required to adequately justify treatment of patients both before and after surgery for resectable NSCLC prior to an approval that would include both neoadjuvant and adjuvant therapy.