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In January, the EMA’s safety committee, PRAC, launched a review after several reports of new cancers in patients receiving CAR-T treatment, which is a process where T cells, a type of immune cells, are purified from the patient’s blood, reprogrammed and re-injected to target the cancer.
The Committee reviewed 38 cases of secondary T-cell malignancies, including T-cell lymphoma and leukaemia, reported among approximately 42,500 patients who have been treated with CAR T-cellmedicines.
By studying tissue samples, seven cases were identified where data suggest that the CAR-T drugs were involved in the development of the disease.
“The secondary malignancies of T-cell origin have been reported within weeks and up to several years after administration of CAR-T cell medicines. Patients treated with these medicines should be monitored life-long for new malignancies,” the EMA writes on its website.
Currently, six CAR-T cell products are approved in the EU for various blood cancers: Abecma, Breyanzi, Carvykti, Kymriah, Tecartus and Yescarta.
Already in November 2023, the US authorities issued a warning about the occurrence of secondary cancers after CAR-T treatments.
However, a study from Stanford Medicine, recently published in the New England Journal of Medicine, indicates that the risk is relatively low. The study included 724 patients who received CAR-T treatment and found that about 6.5% had developed secondary blood cancers at a follow-up at a median of three years after treatment.
According to the researchers, the study results suggest that the secondary cancers are likely to be linked to the immunosuppression resulting from CAR-T cell therapy rather than to the CAR-T cells themselves.