EMA to Require Secondary Cancer Risk Warning for CAR T-Cell Therapies

The European Medicines Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) will require the manufacturers of six approved chimeric antigen receptor (CAR) T-cell therapies to include a warning for the risk of secondary malignancies of T-cell origin, the agency announced June 14.

The PRAC’s conclusion follows a review of 38 cases of secondary T-cell malignancies, including T-cell lymphoma and leukemia, reported among approximately 42,500 patients who have been treated with CAR T-cell therapies. Tissue samples were tested in half of the cases, revealing the presence of the CAR construct in seven cases. According to the EMA, this suggests that the CAR T-cell therapy was involved in disease development.

The EMA’s decision follows a similar move by the U.S. Food and Drug Administration in April that requires manufacturers of BCMA- and CD19-directed CAR T-cell therapies to include a boxed warning for secondary T-cell malignancies. Subsequent research suggests that the overall risk of secondary T-cell malignancies is low.