其 他 安 全 警 示
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| The United States: FDA investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies (English only) |
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The US Food and Drug Administration (FDA) announces that it 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 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 include the following:
- Abecma (idecabtagene vicleucel)
- Breyanzi (lisocabtagene maraleucel)
- Carvykti (ciltacabtagene autoleucel)
- Kymriah (tisagenlecleucel)
- Tecartus (brexucabtagene autoleucel)
- Yescarta (axicabtagene ciloleucel)
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 United States prescribing information for approved BCMA-directed and CD19-directed genetically modified autologous T cell immunotherapies. The initial approvals of these products included postmarketing requirements under Section 505(o) of the Federal Food, Drug, and Cosmetic Act 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 CAR transgene.
Please refer to the following website in FDA for details:
http://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-investigating-serious-risk-t-cell-malignancy-following-bcma-directed-or-cd19-directed-autologous
In Hong Kong, Kymriah Dispersion For Infusion (HK-66588) is a pharmaceutical product registered by Novartis Pharmaceuticals (HK) Limited. It is a prescription-only medicine. So far, with regard to tisagenlecleucel, the Department of Health (DH) has received 18 cases of adverse drug reaction, of which 8 cases were reported as malignancies. The current product insert of the locally registered Kymriah product includes safety information on secondary malignancies – Patients treated with Kymriah may develop secondary malignancies or recurrence of their cancer. They should be monitored life-long for secondary malignancies.
The other products mentioned in the above FDA’s announcement are not registered pharmaceutical products in Hong Kong.
As the FDA’s investigation is ongoing, the DH will remain vigilant on the result of the investigation and safety update of the drugs issued by FDA and other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Wednesday, Nov 29, 2023
Issued at HKT 16:00
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