CAR-T Immunotherapy Under FDA Investigation for 'Serious Cancer Risks'

The agency has received reports of malignancies, including certain types of lymphoma, in people with cancer treated with two types of CAR-T cell immunotherapies.

On November 28, the FDA announced it's investigating a serious safety risk associated with CAR-T cell immunotherapies used to treat blood cancers. The agency initiated the investigation after receiving reports of T-cell malignancies, including certain types of lymphoma, in people with cancer treated with the drugs. These malignancies could lead to hospitalization and death.

The investigation involves all BCMA- or CD19-directed autologous CAR-T cell immunotherapies, including:

  • Abecma (idecabtagene vicleucel)
  • Breyanzi (lisocabtagene maraleucel)
  • Carvykti (ciltacabtagene autoleucel)
  • Kymriah (tisagenlecleucel)
  • Tecartus (brexucabtagene autoleucel)
  • Yescarta (axicabtagene ciloleucel)

The FDA says though the benefits of these medications continue to outweigh the potential risks, the agency is evaluating whether it will take regulatory action due to the T-cell malignancy risks.

Gilead, the pharmaceutical company that makes Tecartus and Yescarta, told Reuters it cooperated with the FDA after the agency requested an analysis of product data. The company also said no evidence indicated that treatment with its CAR-T cell therapies caused new malignancies.

Nonetheless, the FDA says that healthcare providers should monitor people who received these medications for any new cancers for the rest of their lives.

If a malignancy occurs, healthcare providers can contact the drug makers to report the new cancer case and receive instructions on collecting samples to test for the chimeric antigen receptor (CAR) transgene. In addition, they can also report adverse events related to CAR-T cell therapy through the FDA's MedWatch system.

What is CAR-T cell therapy?

Chimeric antigen receptors (CAR) T-cell therapy uses genetically altered white blood cells called T-cells to attack cancer cells. To accomplish this, T-cells are removed from the person with cancer, and then lab technicians add a gene for a chimeric antigen receptor. Once the T-cells are modified and reproduced in the lab, they are returned to the person through infusion.

Then, the new T-cells multiply in the person's body and attack cancer by attaching to specific antigens produced by cancer cells.

Though effective against some types of cancer, CAR-T cell therapy can cause serious and potentially life-threatening side effects, including nervous system issues, immune system conditions, and allergic reactions.

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