FDA updates for Car-T therapies regarding risk of blood cancer.

The agency will require a boxed warning for the cell therapies to reflect the risk of T-cell malignancies based on adverse event and clinical trial reports. Hospitalizations and deaths were in some of those reports. Those malignancies include "CAR-positive tumors, following treatment with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies," the FDA said in letters to the impacted drugmakers. The treatments impacted are Bristol-Myers Squibb's Breyanzi, Bristol and 2seventy bio's Abecma, Johnson & Johnson unit Janssen and Legend Biotech's (LEGN) Carvykti, Novartis' Kymriah, and Gilead Sciences unit Kite's Tecartus and Yescarta.

In late November 2023, the FDA said it was looking into reports of T-cell malignancies associated with CAR-T therapies.