The European Medicines Agency review of the initial application of atezolizumab and the role of PD-L1 expression as biomarker for checkpoint inhibitors

ESMO Open

article

I. Araujo-Fernandez¹  J. Delgado¹  L. Moscetti¹  S.B. Sarac⁵  H. Zander⁷  S. Mueller-Egert⁷  K. Dunder⁶  E. Pean¹  L. Bergmann⁹  H. Enzmann⁶  F. Pignatti¹ 

[1] Oncology and Haematology Office, European Medicines Agency;Agence Nationale de Sécurité du Médicament et des Produits de Santé;Department of Haematology, Hospital Clinic;Department of Oncology, Azienda Ospedaliero-Universitaria di Modena;Danish Medicines Agency;Committee for Medicinal Products for Human Use;Paul Ehrlich Institut;Lakemedelsverket;Universitatsklinikum Frankfurt;Bundesinstitut fur Arzneimittel und Medizinprodukte

关键词: atezolizumab;    TECENTRIQ;    biomarkers;    lung cancer;    bladder cancer;    PD-L1 expression;    EMA;   

DOI  :  10.1016/j.esmoop.2020.100008

学科分类：社会科学、人文和艺术（综合）

来源: BMJ Publishing Group

【 摘 要 】

Immune checkpoint inhibitors have revolutionised cancer therapeutics. Translational research evaluating the role of biomarkers is essential to identify the ideal target population for these drugs. From a regulatory perspective, the identification of biomarkers and diagnostic assays is strongly encouraged by the European Medicines Agency (EMA). The aim of this article is to analyse the role of programmed death-ligand 1 (PD-L1) expression as a predictive biomarker in relation to the data submitted for the initial assessment of atezolizumab, a monoclonal antibody targeting human PD-L1. On 20 July 2017, atezolizumab was granted a marketing authorisation valid throughout the European Union (EU) for adult patients with (i) locally advanced or metastatic non-small-cell lung cancer (NSCLC) after chemotherapy and (ii) locally advanced or metastatic urothelial carcinoma (UC) after chemotherapy or cisplatin-ineligibility. Initially, these indications were not restricted by the level of PD-L1 expression, but preliminary data from an ongoing phase III trial in patients with UC led to a restriction in the UC indication to cisplatin-ineligible patients whose tumours have ≥5% PD-L1 expression. Still, the role of PD-L1 expression as predictive biomarker for atezolizumab therapy remains inconclusive and further research is needed. Data in this paper came from the scientific review leading to the initial regulatory approval of atezolizumab in the EU and its complementary application for indication (EMEA/H/C/004143/II/0010). The full scientific assessment report and product information are available on the EMA website (www.ema.europa.eu).

【 授权许可】

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