FDA Raises Concerns Over Potential Overtreatment with AstraZeneca’s Imfinzi for NSCLC

1. FDA Concerns: The FDA has raised concerns about potential overtreatment with AstraZeneca's Imfinzi (durvalumab) for resectable non-small cell lung cancer (NSCLC) in the perioperative setting, citing excessive exposure to immune checkpoint inhibitors (ICIs) and attendant toxicities.
2. AEGEAN Trial: The Phase III AEGEAN study showed Imfinzi's efficacy in combination with chemotherapy before surgery and as a monotherapy after, but the FDA questions the need for adjuvant Imfinzi on top of neoadjuvant chemoimmunotherapy, citing "high uncertainty" around the contribution of phases.
3. Imfinzi Mechanism: Imfinzi works by blocking the interaction between the PD-L1 protein and its receptor, disrupting the downstream signaling pathway and boosting the body's anti-cancer activity.
4. Current Indications: Imfinzi is currently approved for stage III unresectable NSCLC as a monotherapy and in combination with Imjudo (tremelimumab) and platinum chemotherapy for metastatic disease.
5. AstraZeneca's Proposal: AstraZeneca proposes using Imfinzi in the perioperative setting, both before and after surgical resection of the tumor, which the FDA is reviewing at an advisory committee meeting.