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The European Medicines Agency Review of Tafasitamab in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

Tafasitamab is a humanized monoclonal antibody that binds to the CD19 antigen, which is expressed in tumor cells from patients with diffuse large B-cell lymphoma (DLBCL). On June 24, 2021, a positive opinion for a conditional marketing authorization was issued by the European Medicines Agency (EMA)’...

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Autores principales: Delgado, Julio, Papadouli, Irene, Sarac, Sinan B., Moreau, Alexandre, Hovgaard, Doris, Gisselbrecht, Christian, Enzmann, Harald, Pignatti, Francesco
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8601272/
https://www.ncbi.nlm.nih.gov/pubmed/34805769
http://dx.doi.org/10.1097/HS9.0000000000000666
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author Delgado, Julio
Papadouli, Irene
Sarac, Sinan B.
Moreau, Alexandre
Hovgaard, Doris
Gisselbrecht, Christian
Enzmann, Harald
Pignatti, Francesco
author_facet Delgado, Julio
Papadouli, Irene
Sarac, Sinan B.
Moreau, Alexandre
Hovgaard, Doris
Gisselbrecht, Christian
Enzmann, Harald
Pignatti, Francesco
author_sort Delgado, Julio
collection PubMed
description Tafasitamab is a humanized monoclonal antibody that binds to the CD19 antigen, which is expressed in tumor cells from patients with diffuse large B-cell lymphoma (DLBCL). On June 24, 2021, a positive opinion for a conditional marketing authorization was issued by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) for tafasitamab, in combination with lenalidomide, for the treatment of adult patients with relapsed or refractory DLBCL who are ineligible for autologous stem cell transplantation. Tafasitamab was evaluated in the phase 2 single-arm, multicenter, open-label L-MIND clinical trial. The primary endpoint of this trial was objective response rate (ORR). The best ORR, achieved at any time during the study, was 56.8% (95% confidence interval: 45.3%–67.8%), and the median duration of response was 34.6 months (95% confidence interval: 26.1–not reached). The most frequently reported adverse events by system organ class were infections and infestations (72.8%; grade ≥3: 29.6%), blood and lymphatic system disorders (65.4%; grade ≥3: 56.8%), gastrointestinal disorders (64.2%; grade ≥3: 2.5%), and general disorders and administration site conditions (58.0%; grade ≥3: 8.6%). The aim of this article is to summarize the scientific review of the application which led to the positive opinion by the CHMP.
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spelling pubmed-86012722021-11-19 The European Medicines Agency Review of Tafasitamab in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma Delgado, Julio Papadouli, Irene Sarac, Sinan B. Moreau, Alexandre Hovgaard, Doris Gisselbrecht, Christian Enzmann, Harald Pignatti, Francesco Hemasphere Review Article Tafasitamab is a humanized monoclonal antibody that binds to the CD19 antigen, which is expressed in tumor cells from patients with diffuse large B-cell lymphoma (DLBCL). On June 24, 2021, a positive opinion for a conditional marketing authorization was issued by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) for tafasitamab, in combination with lenalidomide, for the treatment of adult patients with relapsed or refractory DLBCL who are ineligible for autologous stem cell transplantation. Tafasitamab was evaluated in the phase 2 single-arm, multicenter, open-label L-MIND clinical trial. The primary endpoint of this trial was objective response rate (ORR). The best ORR, achieved at any time during the study, was 56.8% (95% confidence interval: 45.3%–67.8%), and the median duration of response was 34.6 months (95% confidence interval: 26.1–not reached). The most frequently reported adverse events by system organ class were infections and infestations (72.8%; grade ≥3: 29.6%), blood and lymphatic system disorders (65.4%; grade ≥3: 56.8%), gastrointestinal disorders (64.2%; grade ≥3: 2.5%), and general disorders and administration site conditions (58.0%; grade ≥3: 8.6%). The aim of this article is to summarize the scientific review of the application which led to the positive opinion by the CHMP. Lippincott Williams & Wilkins 2021-11-18 /pmc/articles/PMC8601272/ /pubmed/34805769 http://dx.doi.org/10.1097/HS9.0000000000000666 Text en Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the European Hematology Association. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article distributed under the Creative Commons Attribution-NoDerivatives License 4.0 (https://creativecommons.org/licenses/by-nd/4.0/) , which allows for redistribution, commercial and non-commercial, as long as it is passed along unchanged and in whole, with credit to the author.
spellingShingle Review Article
Delgado, Julio
Papadouli, Irene
Sarac, Sinan B.
Moreau, Alexandre
Hovgaard, Doris
Gisselbrecht, Christian
Enzmann, Harald
Pignatti, Francesco
The European Medicines Agency Review of Tafasitamab in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
title The European Medicines Agency Review of Tafasitamab in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
title_full The European Medicines Agency Review of Tafasitamab in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
title_fullStr The European Medicines Agency Review of Tafasitamab in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
title_full_unstemmed The European Medicines Agency Review of Tafasitamab in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
title_short The European Medicines Agency Review of Tafasitamab in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
title_sort european medicines agency review of tafasitamab in combination with lenalidomide for the treatment of adult patients with relapsed/refractory diffuse large b-cell lymphoma
topic Review Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8601272/
https://www.ncbi.nlm.nih.gov/pubmed/34805769
http://dx.doi.org/10.1097/HS9.0000000000000666
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