The FDA has received reports of T-cell malignancies in patients who have been treated with CD19- or BCMA-directed autologous CAR T-cell immunotherapies.1 These T-cell malignancies include CAR-positive lymphoma and were reported from postmarketing adverse effect (AE) data sources and clinical trials in patients who received several CAR T-cell products in the class.

The FDA has determined that the risk of T-cell malignancies is apparent in all currently approved CD19- and BCMA-directed genetically modified autologous CAR T-cell immunotherapies, including:

The FDA emphasizes that although the benefits of these products in their indicated uses continue to outweigh their potential risks, it is investigating the identified risk of T-cell malignancy, which may have serious outcomes, such as hospitalization and death.1 The agency is evaluating whether regulatory action pertaining to this risk is necessary.

All gene therapy products with integrating lentiviral or retroviral vectors, including CD19- and BCMA-directed genetically modified autologous T-cell immunotherapies, are labeled with a United States prescribing information class warning for the development of secondary malignancies. The initial FDA approvals of these products included postmarketing requirements per Section 505(o) of the Federal Food, Drug, and Cosmetic Act for investigators to conduct 15-year observational follow-up safety studies for the purpose of assessing the long-term safety profiles of these products and the risk of developing secondary malignancies after treatment.

Patients being treated with these CD19- and BCMA-directed genetically modified autologous T-cell immunotherapies should receive life-long monitoring for the development of new malignancies. If a patient develops a new malignancy after receiving treatment with these products, they should contact the respective products manufacturer to report the incident and receive instructions regarding the collection of patient samples that will be tested for the presence of the CAR transgene.

Suspected AEs, including T-cell malignancies, related to these products can be reported to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

Health care providers, clinical investigators, caregivers, and patients with questions about these products can contact the FDAs Center for Biologics Evaluation and Research atocod@fda.hhs.gov.

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T-Cell Malignancies Reported in Patients Who Received BCMA ... - OncLive