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EMA: “monitored LIFE-LONG”

14 Giugno 2024 by

… a new cancer, different from the previous one

… may occur after treatment with chimeric antigen receptor (CAR) T-cell medicines

… evaluated data on 38 cases of secondary malignancy

… reported among approximately 42,500 patients who have been treated

… Tissue samples were tested 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 disease development

… secondary malignancies … reported within weeks and up to several years following administration

… Patients treated with these medicines should be monitored life-long for new malignancies

… Six CAR T-cell products are approved in the European Union

… Abecma, Breyanzi, Carvykti, Kymriah, Tecartus and Yescarta

… are used to treat blood cancers

… in patients whose cancer has come back (relapsed) or has stopped responding to previous treatment (refractory)

… The product information and the risk management plans will be updated to include the new information concerning secondary malignancy of T-cell origin

 

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