The Committee will discuss the supplementary Biological Marketing Authorization 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 approval that includes both neoadjuvant and adjuvant therapy.

Please take the opportunity to connect and share this video with your friends and family if you find it helpful.