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Poster Display session

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


31 Mar 2023


Poster Display session


Numair Rizwan


Journal of Hepatology (2023) 18 (4S): S154-S159.


N. Rizwan1, D. Pottinger2, R. Singh3, K. Jatwani4, A. Khosla5, D.T. Michaeli6, T. Michaeli6, J. Warner7, M.P. Lythgoe8, A.R. Khaki9, A. Desai10

Author affiliations

  • 1 Hradec Kralove/CZ
  • 2 University of Alabama at Birmingham, Birmingham/US
  • 3 University of Vermont - Larner College of Medicine, Burlington/US
  • 4 Roswell Park Comprehensive Cancer Center, Buffalo/US
  • 5 Miami Cancer Institute, Baptist Health South Florida, Miami/US
  • 6 University Hospital Mannheim, Heidelberg University, Mannheim/DE
  • 7 Brown University, Providence/US
  • 8 Imperial College Healthcare NHS Trust, London/GB
  • 9 Stanford University, Stanford/US
  • 10 Mayo Clinic, Jacksonville/US


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Abstract 216P


Given the paradigm-shifting impact of ICIs on the treatment of lung cancer, prompt approval of therapies is crucial for patients. In this study, we analyzed differences in approval timing, regulatory review speed and biomarker requirements for ICI approvals by the FDA and EMA. For indications with differing biomarker requirements, we further examined perceived differences in levels of evidence.


A cross-sectional analysis of approved indications for ICIs from each regulatory database was conducted by tumor type: NSCLC, SCLC and Mesothelioma. The median review speed (Time from regulatory submission to approval) and differences in biomarker requirements (primarily PD-L1 expression) were evaluated. Levels of evidence for indications was determined by NCCN evidence blocks and ESMO MCBS scoring systems.


We identified 7 ICIs approved for thoracic malignancies. For NSCLC, the FDA approved 19 anti-PD1/PD-L1 and 3 anti-CTLA-4 indications while the EMA approved 14 anti-PD1/PD-L1 and 1 anti-CTLA-4 indications. For SCLC, the FDA approved 4 anti-PD1/PD-L1 indications (1 was later withdrawn), while EMA approved 2 anti-PD1/PD-L1 indications. The median review times for ICI approval was shorter for FDA compared to EMA across all thoracic malignancies (NSCLC: 242 vs 272 days, SCLC: 179 vs 308 days, Mesothelioma: 39 vs 280 days). Analysis of biomarker requirements revealed 2 indications for which FDA had a broader label compared to EMA. Although both ESMO MCBS and NCCN rank these indications as being effective and beneficial, the biomarker requirements differ between both regulators for unclear reasons.

Table: 216P
IndicationBiomarker requirement differenceESMO MCBS scoreNCCN evidence blocks
Atezolizumab in adjuvant NSCLC (Approvals based on IMPower010)FDA: PDL1 ≥1 % EMA: PDL1 ≥50 %A (Substantial Benefit)4 (Very Effective)
Durvalumab in unresectable NSCLC (Approvals based on PACIFIC)FDA: None EMA: PDL1 ≥1 %A (Substantial Benefit)3 (Moderately Effective)


More ICIs, and total overall indications, have been approved for thoracic malignancies by the FDA with shorter median review times compared to EMA. There is some discordance in biomarker-based approvals between both agencies, although evaluation of evidence scores are fairly consistent.

Legal entity responsible for the study

The authors.


Has not received any funding.


All authors have declared no conflicts of interest.

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