It was January 2024 when the European Medicines Agency EMA announced that it had started a review of 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. Now the conclusions are made known: from the analysis of the data a “risk of secondary malignancies of T cell origin”. This is what the EU regulatory body announced in a note, reporting the outcome of the meeting of the PRAC Pharmacovigilance and Safety Committee and highlighting the need for close monitoring of the people treated.
“The Prac – reads the note – concluded that secondary malignancies of T cell origin (a new cancer, different from the previous one, which begins in a type of white blood cell of the immune system called T cells) can occur after treatment” with Car-T.
“The committee assessed data on 38 cases of secondary malignancies of T-cell origin, including T-cell lymphoma and T-cell leukemia, reported among approximately 42,500 patients who were treated with CAR-T cell medicines. Tissue samples were analyzed in half of the cases, revealing the presence of the Car construct in 7 cases. This suggests that the Car-T cell medicine was involved in the development of the disease.” Secondary neoplasms of T cell origin have been reported “within weeks and up to several years after” administration of the medicines in question. patients treated with these medicines must therefore “be monitored for life for any new tumors”, concludes the EMA.
To date, 6 Car-T products are approved in the European Union, they are used to treat tumors such as B-cell leukemia, B-cell lymphoma, follicular lymphoma, multiple myeloma and mantle cell lymphoma in patients whose cancer has come back (relapsed) or has stopped responding to previous treatment (refractory).
“Since approval, the product information has warned that patients treated with these products may develop secondary malignancies – recalls the EMA – The product information and risk management plans will be updated to include the new information relating to tumors secondary malignancies of T cell origin”. A direct communication to healthcare professionals (DHPC) is arriving for Abecma, Breyanzi*, Carvykti, Kymriah, Tecartus and Yescarta. The text will be forwarded to the EMA’s CHMP Committee for Medicinal Products for Human Use and, once adopted, will be disseminated by the manufacturing companies to healthcare professionals and published online.
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