The FDA is investigating reports of new cancer developments in patients treated with CAR-T cell immunotherapies, specifically targeting BCMA or CD19. This probe, announced on a recent Tuesday, follows cases from clinical trials and postmarketing surveillance where patients developed T-cell malignancies, including CAR-positive lymphoma. Some of these cases resulted in hospitalization or death. The FDA’s concern extends to all approved CAR-T therapies, as the risk seems to be present across various products.

Currently, the market has several CD19 CAR-T therapies like Yescarta, Tecartus, Kymriah, and Breyanzi, and BCMA therapies such as Carvykti. Incidents of T-cell lymphoma have been reported for several of these products. Despite this, companies like Gilead Sciences and Novartis express confidence in their products, citing a lack of evidence directly linking their therapies to new malignancies. Gilead has treated 17,700 patients without any clear causal relationship. Similarly, Novartis, with over 10,000 patients treated with Kymriah, denies a causal link.

Legend Biotech points out that T-cell malignancies can occur in multiple myeloma patients even without CAR-T treatments, and Johnson & Johnson, makers of Carvykti, have reported a favorable benefit-risk profile from their surveillance data. These companies are cooperating with the FDA, providing data and analyses as the agency considers potential regulatory actions. The risk of developing secondary cancer is already included as a class warning on CAR-T therapy labels.

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