FDA finds link between cancer therapy and new tumors


But the agency says the benefits of CAR T therapy outweigh the risks

In late 2023, the U.S. Food and Drug Administration (FDA) said it was investigating a breakthrough cancer treatment to treatment to learn whether it increased the risk of creating new cancers.

The investigation has concluded and the FDA says it found evidence that the treatment, known as CAR T therapy, does in fact raise the risk of cancer. The agency is instructing drug companies producing the treatment to put a “black box” warning on it, informing users and physicians of the finding.

At the same time, the FDA said the risk appears to be small and the benefits of CAR T therapy appear to outweigh the risks.

The treatment is a cell therapy that increases the patient’s immune system against cancer. A patient’s T cells are removed and genetically modified to make them attack cancer cells, then returned to the patient’s body.

Saved many lives

Researchers say CAR T therapy has saved many lives, often successfully treating cases of blood cancer that were once considered untreatable.

But the therapy is not without potential side effects. In 2023, the FDA began to hear from doctors that some patients who had undergone the treatment had developed secondary cancers.

FDA scientists who conducted the investigation say it is possible that when the engineered cells are put back into the patient, cell DNA is disrupted, leading to the development of new tumors. The investigation was triggered by 19 cases, in which patients who received the therapy developed new tumors.

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