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01-02-2019 | Acute Lymphoblastic Leukemia | Stem Cell Transplantation (R Maziarz, Section Editor)

Industry’s Giant Leap Into Cellular Therapy: Catalyzing Chimeric Antigen Receptor T Cell (CAR-T) Immunotherapy

Authors: Stacie Ittershagen, Solveig Ericson, Lamis Eldjerou, Ali Shojaee, Eric Bleickardt, Manisha Patel, Tetiana Taran, Oezlem Anak, Charlene Hall, Mimi Leung, Deborah Roccoberton, Florence Salmon, Miriam Fuchs, Vadim Romanov, David Lebwohl

Published in: Current Hematologic Malignancy Reports | Issue 1/2019

Abstract

Purpose of Review

We describe the significant technological leap from bench to bedside that was achieved through a strong academic-industry collaboration between dedicated clinicians and researchers at the University of Pennsylvania, the Children’s Hospital of Philadelphia, and Novartis to commercialize the chimeric antigen receptor T cell (CAR-T) therapy tisagenlecleucel (CTL019; Kymriah®; Novartis Pharma AG, Basel, Switzerland).

Recent Findings

Tisagenlecleucel was the first CAR-T therapy and the first gene therapy to receive US Food and Drug Administration approval in 2017, with an initial indication for pediatric and young adult patients with relapsed or refractory (r/r) acute lymphoblastic leukemia, followed by approval in May 2018 for a second indication in adult patients with r/r diffuse large B cell lymphoma. Subsequent approvals in the European Union, Switzerland, and Canada soon followed.

Summary

The tisagenlecleucel success story represents the development and commercialization of a first-of-its-kind personalized cellular therapy with a manufacturing process that supports commercial production and ongoing global clinical trials in a growing number of countries.

Available only for authorised users

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Title: Industry’s Giant Leap Into Cellular Therapy: Catalyzing Chimeric Antigen Receptor T Cell (CAR-T) Immunotherapy
Authors: Stacie Ittershagen
Solveig Ericson
Lamis Eldjerou
Ali Shojaee
Eric Bleickardt
Manisha Patel
Tetiana Taran
Oezlem Anak
Charlene Hall
Mimi Leung
Deborah Roccoberton
Florence Salmon
Miriam Fuchs
Vadim Romanov
David Lebwohl
Publication date: 01-02-2019
Publisher: Springer US
Keywords: Acute Lymphoblastic Leukemia
Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma
Leukemia
Published in: Current Hematologic Malignancy Reports / Issue 1/2019
Print ISSN: 1558-8211
Electronic ISSN: 1558-822X
DOI: https://doi.org/10.1007/s11899-019-0498-6

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