216P Differences in immune checkpoint inhibitor (ICI) approvals made by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for thoracic malignancies

Given the paradigm-shifting impact of ICIs on treatment lung cancer, prompt approval therapies is crucial for patients. In this study, we analyzed differences in timing, regulatory review speed and biomarker requirements ICI approvals by FDA EMA. For indications with differing requirements, further examined perceived levels evidence. A cross-sectional analysis approved from each database was conducted tumor type: NSCLC, SCLC Mesothelioma. The median (Time submission to approval) (primarily PD-L1 expression) were evaluated. Levels evidence determined NCCN blocks ESMO MCBS scoring systems. We identified 7 thoracic malignancies. 19 anti-PD1/PD-L1 3 anti-CTLA-4 while EMA 14 1 indications. SCLC, 4 (1 later withdrawn), 2 times shorter compared across all malignancies (NSCLC: 242 vs 272 days, SCLC: 179 308 Mesothelioma: 39 280 days). Analysis revealed which had a broader label Although both rank these as being effective beneficial, differ between regulators unclear reasons. Table 216PIndicationBiomarker requirement differenceESMO scoreNCCN blocksAtezolizumab adjuvant NSCLC (Approvals based IMPower010)FDA: PDL1 ≥1 % EMA: ≥50 %A (Substantial Benefit)4 (Very Effective)Durvalumab unresectableFDA: NoneA3NSCLC PACIFIC)EMA: ≥1%(Substantial Benefit)(Moderately Effective) Open table new tab More ICIs, total overall indications, have been There some discordance biomarker-based agencies, although evaluation scores are fairly consistent.