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Tisagenlecleucel FDA Alerts

The FDA Alerts below may be specifically about tisagenlecleucel or relate to a group or class of drugs which include tisagenlecleucel.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for tisagenlecleucel

Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies Modified to Minimize Burden on Healthcare Delivery System

Jun 26, 2024 | Audience: Health Professional

June 26, 2024 -- Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies Modified to Minimize Burden on Healthcare Delivery System

A Risk Evaluation and Mitigation Strategy (REMS) is a safety program that the Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. Because of the risks of cytokine release syndrome (CRS) and neurological toxicities, the following currently approved (listed alphabetically by trade name) BCMA- or CD19-directed autologous CAR T cell immunotherapies are available only through a restricted program under a REMS:

In accordance with section 505-1(g)(4)(B) of the Federal Food, Drug, and Cosmetic Act (FDCA), FDA determined that the approved REMS for these products must be modified to minimize the burden of complying with the REMS on the healthcare delivery system. Currently, information regarding the risks for CAR T cell immunotherapies can be conveyed adequately via the current product labeling, which includes a boxed warning for the risks of CRS and neurological toxicities, and the Medication Guides which are a part of the approved labeling. Thus, the REMS have been modified to remove requirements for educational and training materials. Additionally, the requirement to report adverse events suggestive of CRS or neurological toxicities to the REMS has been removed. Adverse event reporting requirements in accordance with 21 CFR 600.80 are adequate for continued routine safety monitoring for these products.

The goal of the modified REMS is to mitigate the risks of CRS and neurological toxicities by ensuring that hospitals and their associated clinics that dispense the above products are specially certified and have on-site, immediate access to tocilizumab. The REMS for each product (implemented at the time that the original Biologics License Application for each product was approved) requires that a minimum of two doses of tocilizumab must be available on-site for each patient before infusion of the CAR T cell immunotherapy. The currently approved REMS are available at REMS@FDA.

To report suspected adverse events, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Healthcare providers, clinical investigators, patients and caregivers who have questions may contact FDA’s Center for Biologics Evaluation and Research (CBER) at ocod@fda.hhs.gov.

Source: FDA

FDA Requires Boxed Warning for T Cell Malignancies Following Treatment with BCMA-Directed or CD19-Directed Autologous CAR T Cell Immunotherapies

Apr 18, 2024 | Audience: Health Professional

April 18, 2024 -- In November 2023, the Food and Drug Administration (FDA) posted a safety communication to provide information about reports of T cell malignancies including chimeric antigen receptor CAR-positive lymphoma in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies. Reports were received from clinical trials and/or postmarketing adverse event data sources.

Currently approved products in this class (listed alphabetically by trade name) include the following:

FDA also listed post-treatment T cell malignancy as a potential signal of serious risk/new safety information for this product class, identified by FDA Adverse Event Reporting System (FAERS) in the July - September 2023 quarterly report. FDA concluded, based on an evaluation of data from postmarketing adverse event and clinical trial reports, that mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. FDA has determined that the serious risk of T cell malignancies is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies. Therefore, in January 2024, FDA initiated class safety labeling changes (2024 Safety and Availability Communications). FDA concluded that changes to the Boxed Warning are warranted to highlight the serious risk of T cell malignancies. In addition, FDA has required related updates to other sections of the label (Warnings and Precautions, Postmarketing Experience, Patient Counseling Information and Medication Guide).

Patients and clinical trial participants receiving treatment with these products should be monitored life-long for secondary malignancies. In the event that a new malignancy occurs following treatment with these products, contact the manufacturer to report the event and obtain instructions on collection of patient samples for testing for the presence of the CAR transgene. To report suspected adverse events including T cell malignancies, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Healthcare providers, clinical investigators, patients, and caregivers who have questions may contact FDA’s Center for Biologics Evaluation and Research (CBER) at ocod@fda.hhs.gov.

Source: FDA

FDA Investigating Serious Risk of T-cell Malignancy Following BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies

Nov 28, 2023 | Audience: Health Professional

November 28, 2023 -- The Food and Drug Administration (FDA) has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies. Reports were received from clinical trials and/or postmarketing adverse event (AE) data sources.

FDA has determined that the risk of T-cell malignancies is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies. T-cell malignancies have occurred in patients treated with several products in the class. Currently approved products in this class (listed alphabetically by trade name) include the following:

Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory action.

As with all gene therapy products with integrating vectors (lentiviral or retroviral vectors), the potential risk of developing secondary malignancies is labeled as a class warning in the U.S. prescribing information (USPIs) for approved BCMA-directed and CD19-directed genetically modified autologous T cell immunotherapies. The initial approvals of these products included postmarketing requirements (PMRs) under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to conduct 15-year long term follow-up observational safety studies to assess the long-term safety and the risk of secondary malignancies occurring after treatment.

Patients and clinical trial participants receiving treatment with these products should be monitored life-long for new malignancies. In the event that a new malignancy occurs following treatment with these products, contact the manufacturer to report the event and obtain instructions on collection of patient samples for testing for the presence of the Chimeric Antigen Receptor (CAR) transgene.

To report suspected adverse events including T cell malignancies, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Healthcare providers, clinical investigators, patients, and caregivers who have questions may contact FDA’s Center for Biologics Evaluation and Research (CBER) at ocod@fda.hhs.gov.

Source: FDA

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