The European Medicines Agency (EMA) has initiated a safety review of 6 Car-T products approved for use in the European Union due to the potential risk of cell-related secondary malignancies, including T-cell lymphoma and T-cell leukemia. Car-T therapies are personalized immunotherapies based on the patient’s T lymphocytes and are used to treat various blood tumors such as leukemia and lymphoma.
The EMA’s Pharmacovigilance Committee has decided to examine all available evidence, including information about 23 cases of T-cell lymphoma or leukemia reported in the adverse effects database. The agency will assess the need for any regulatory actions based on the results of this analysis.
The 6 Car-T products authorized in the European Union are Abecma, Breyanzi, Tsarvykti, Kymriah, Tecartus, and Yescarta. These medicines are used in the treatment of blood tumors such as leukemia and lymphoma in patients whose cancer has come back or stopped responding to previous therapy.
The EMA emphasizes that the potential risk of secondary tumors was already considered at the time of authorization for these Car-T therapies and was included in their risk management plans. The agency reassures that a careful monitoring approach is already in place and marketing authorization holders are required to regularly submit provisional results of long-term safety and efficacy studies as part of periodic safety update reports.
This safety review underscores the importance of ongoing vigilance and monitoring of the long-term effects and safety of Car-T therapies in cancer treatment.