FDA Mandates Black Box Warning for All Commercial CAR-T Therapies Due to Secondary T-Cell Cancer Risk

January 23, 2024

The FDA is set to add a black box warning, the most severe safety alert, for all six commercial CAR-T therapies due to the risk of secondary T-cell cancers. This decision impacts products from Bristol Myers Squibb, Gilead Sciences’ Kite Pharma, Johnson & Johnson, and Novartis, including treatments for multiple myeloma and large B-cell lymphoma. The warning will specifically mention the risk of T-cell malignancies following treatment with these therapies. The update follows an FDA investigation that deemed this risk serious. Companies can comply with the FDA’s wording for label changes, propose alternative wording, or submit a rebuttal. Failure to respond within 30 days could result in enforcement actions. Despite the warning, the FDA maintains that the benefit-risk profiles of these therapies remain favorable, and CAR-T pioneers suggest continuing their use based on current safety data. The impact on the approval process for these therapies, as they move into earlier lines of treatment, remains uncertain.

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[Source: Fierce Pharma, January 23rd, 2024]

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