The European Medicines Agency EMA announces the launch of a review into the safety of anti-cancer CAR-Ts, personalized immunotherapies based on the patient’s T lymphocytes which are taken, reprogrammed to attack the tumor and then reinfused. The EMA’s PRAC Pharmacovigilance Committee, meeting from 8 to 11 January, decided to review the 6 Car-T products approved in the European Union, for the risk of “secondary malignancies related to T cells, including lymphoma and T-cell leukemia”.
The PRAC, informs the EMA, is examining “all available evidence, including information on 23 cases of various types of T-cell lymphoma or leukemia reported on EudraVigilance, the EU database of adverse drug effects”. Based on the results of the analysis, the panel will “decide on the need for any regulatory action.”
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6 Car-T-cells authorized in the European Union
The 6 Car-T-cells authorized in the European Union are Abecma*, Breyanzi*, Carvykti*, Kymriah*, Tecartus* and Yescarta*, lists the EMA. These medicines – recalls the EU regulatory body – are used to treat blood cancers such as leukemia and B-cell lymphoma, follicular lymphoma, multiple myeloma and mantle cell lymphoma, in patients whose cancer has come back or has stopped respond to previous therapy.
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A secondary neoplasm – specifies the EMA – is one that occurs when a patient who has a current or previous cancer develops a second tumor different from the first. For all 6 Car-T products mentioned above “secondary tumors were considered an important potential risk” already “at the time of their authorization” and for this reason they were “included in the risk management plans (RMP)”, points out the ‘agency. Therefore, “careful monitoring is already underway – assures the EMA – and the holders of the marketing authorization for approved medicines are required to regularly submit the provisional results of the long-term safety and efficacy studies imposed and as part of periodic safety update reports (Psur)”.
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