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FDA Evaluates Risk of T-Cell Malignancies in CAR T-Cell Therapies; Novartis, Gilead & Bristol Myers in Focus

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FDA has received reports of patients developing T-cell malignancies after receiving BCMA- or CD19-directed autologous CAR T cell immunotherapies.

The risk of T-cell malignancies applies to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies. Since 2017,ย sixย CAR T-cell therapies have been approved by the FDA.

  • Bristol Myers Squibb & Coโ€™sย BMY Breyanzi (lisocabtagene maraleucel)
  • 2seventy Bio Incย TSVT andย Bristol Myers Squibbโ€™sย Abecma (idecabtagene vicleucel)
  • Johnson & Johnsonโ€™sย JNJ Carvykti (ciltacabtagene autoleucel)
  • Novartis AGโ€™sย NVS Kymriah (tisagenlecleucel)
  • Gilead Science Incโ€™sย GILD Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel)

The FDA is considering โ€œthe need for regulatory actionโ€ following reports tied to the commercial use of CAR-T therapies.

The identified risk applies to all approved CAR-T therapies, yet โ€œthe overall benefits of these products continue to outweigh their potential risks for their approved uses.โ€

The therapies involve extracting a patientโ€™s T cells, genetically engineering them with a chimeric antigen receptor (CAR) to target specific protein flags on malignant cells.

Once reinfused, the CARs recognize and bind to specific proteins, or antigens, on the surface of cancer cells.

Bristol-Myers Squibbโ€™s and 2seventy Bioโ€™s efforts to expand U.S. approval for Abecma geneย therapy experienced a setback.

RBC analysts cited by Reuters expressed concerns, with a focus on Novartisโ€™ Kymriah and extremely rare occurrences for the other marketed CAR-Ts.

Gilead expressed confidence in the safety profile of both Tecartus and Yescarta, stating this to Reuters.

William Blairย notes that the FDA requires more information to assess the prevalence of CAR+ T-cell lymphomas.

Ongoing research indicating long-term effectiveness of the treatment without the need for further intervention could greatly benefit those with autoimmune conditions.

CAR-T cells tend to have a shorter lifespan in autoimmune conditions compared to cancers like lymphomas and multiple myeloma, suggesting a natural removal by healthy immune systems.

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