Biotech Values

[DewDiligence]

Re: CAR-T lymphoma risk

More from the same FDA press release (stock tickers in square brackets added by me):

https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-investigating-serious-risk-t-cell-malignancy-following-bcma-directed-or-cd19-directed-autologous

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.

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

• Abecma (idecabtagene vicleucel) [BMY / TSVT]

• Breyanzi (lisocabtagene maraleucel) [BMY]

• Carvykti (ciltacabtagene autoleucel) [JNJ]

• Kymriah (tisagenlecleucel) [NVS]

• Tecartus (brexucabtagene autoleucel) [GILD]

• Yescarta (axicabtagene ciloleucel) [GILD]

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.