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- Title
A Primer on Chimeric Antigen Receptor T-cell Therapy: What Does It Mean for Pathologists?
- Authors
Cushman-Vokoun, Allison M.; Voelkerding, Karl V.; Fung, Mark K.; Nowak, Jan A.; Thorson, John A.; Duncan, Helena L.; Kalicanin, Tanja; Anderson, Matthew W.; Yohe, Sophia
- Abstract
* Context.--Chimeric antigen receptor T-cell (CAR-T) technology has shown great promise in both clinical and preclinical models in mediating potent and specific antitumor activity. With the advent of US Food and Drug Administration--approved CAR-T therapies for B-cell lymphoblastic leukemia and B-cell non-Hodgkin lymphomas, CAR-T therapy is poised to become part of mainstream clinical practice. Objective.--To educate pathologists on CAR-T and chimeric antigen receptor--derived cellular therapy, provide a better understanding of their role in this process, explain important regulatory aspects of CAR-T therapy, and advocate for pathologist involvement in the delivery and monitoring of chimeric antigen receptor--based treatments. Much of the focus of this article addresses US Food and Drug Administration--approved therapies; however, more general issues and future perspectives are considered for therapies in development. Design.--A CAR-T workgroup, facilitated by the College of American Pathologists Personalized Health Care Committee and consisting of pathologists of various backgrounds, was convened to develop a summary guidance paper for the College of American Pathologists Council on Scientific Affairs. Results.--The workgroup identified gaps in pathologists' knowledge of CAR-T therapy, including uncertainty in the role of the clinical laboratory in supporting CAR-T therapy. The workgroup considered these issues and summarized the findings to assist pathologists to become stakeholders in CAR-T therapy administration. Conclusions.--This manuscript serves to both educate pathologists on CAR-T therapy and serve as a point of initial discussions in areas of CAR-T science, clinical therapy, and regulatory issues as CAR-T therapies continue to be introduced into clinical practice.
- Subjects
THERAPEUTIC use of antineoplastic agents; IMMUNIZATION; PATHOLOGISTS; CELLULAR therapy; CELL receptors; B cell lymphoma; UNITED States. Food &; Drug Administration; PSYCHOSOCIAL factors; LYMPHOCYTIC leukemia; LYMPHOMAS
- Publication
Archives of Pathology & Laboratory Medicine, 2021, Vol 145, Issue 6, p704
- ISSN
0003-9985
- Publication type
Article
- DOI
10.5858/arpa.2019-0632-CP