CAR T-cell meds: PRAC identifies risk of secondary malignancies of T-cell origin

At its June meeting, the European Medicines Agency’s (EMA) pharmacovigilance committee, PRAC, came to the conclusion that patients treated with CAR T-cell medicines should be monitored life-long for secondary malignancies.

The PRAC has concluded that secondary malignancies of T-cell origin (a new cancer, different from the previous one, that begins in a type of white blood cells of the immune system called T-cells) may occur after treatment with chimeric antigen receptor (CAR) T-cell medicines.

The committee evaluated data on 38 cases of secondary malignancy of T-cell origin, including T-cell lymphoma and leukemia, reported among approximately 42,500 patients who have been treated with CAR T-cell medicines. Tissue samples were tested in half of the cases, revealing the presence of the CAR construct in seven cases. This suggests that the CAR T-cell medicine was involved in disease development. The secondary malignancies of T-cell origin have been reported within weeks and up to several years following administration of CAR T-cell medicines. Patients treated with these medicines should be monitored life-long for new malignancies.