Blood cancer treatments may sometimes cause cancer: FDA

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WASHINGTON, Dec 2, (Agencies): A groundbreaking cancer treatment, utilized since 2017 for various blood cancers, is now under scrutiny as it has been associated with the onset of lymphoma. The FDA recently disclosed the discovery of several lymphoma cases in patients who underwent CAR-T treatments, a process involving the replication and reprogramming of a patient’s T cells, a type of white blood cell. These modified cells are then reintroduced into the patient’s body to target and eliminate cancer cells.

The FDA’s investigation revealed that CAR-T treatments, originally designed to combat diseases like non-Hodgkin lymphoma, leukemia, and myeloma, are implicated in the development of malignancies, particularly lymphoma. The regulatory agency emphasized that the risk of T-cell malignancies, including lymphoma, is applicable to all currently approved immunotherapies used by patients.

Despite these findings, the FDA emphasized that the overall benefits of CAR-T treatments still outweigh potential risks. However, the agency is closely examining cases where T-cell malignancies led to severe outcomes such as hospitalization and death.

Dr. John DiPersio from Washington University School of Medicine, where the treatment has been administered to an estimated 500-700 patients, reported not encountering a single case of a new cancer arising from the treatment. He highlighted that CAR-T therapy is a lifeline for patients facing imminent death due to their diagnosis. Dr. DiPersio stressed its life-saving impact, stating that it works significantly in a substantial portion of patients.

Dr. Marcela V. Maus, the director of cellular immunotherapy at Massachusetts General Hospital, echoed Dr. DiPersio’s positive outlook, stating that they have not observed malignancies associated with the treatment.

The FDA, in its release, mentioned that it is still evaluating the necessity for regulatory action in light of these findings, emphasizing the need for continued vigilance and investigation into the potential risks associated with CAR-T treatments.

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