CAR-T gelinked aan secondaire tumoren

The European Medicines Agency (EMA), through the Pharmacovigilance Risk Assessment Committee (PRAC), has concluded that therapy with CAR-T cells may be directly linked to the onset of tumors originating from T lymphocytes. CAR-T is studied (ao -Uro Oncology) in testicular carcinoma and renal cell carcinoma.

Read: EMA Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2024


The news was disseminated on the EMA website at the same time as the New England Journal of Medicine published two articles describing secondary tumors in patients treated with CAR-T cells.

The first study on secondary tumors, published in The New England Journal of Medicine, comes from Georgetown University in Washington, DC. The authors described a CD4-positive indolent lymphoma diagnosed in a patient who had been treated 5 months earlier with CAR-T cells for myeloma. The DNA of the tumor cells contained a sequence attributable to the construct used to engineer the cells. Researchers identified numerous genetic alterations that could have contributed to the neoplastic transformation.

Read: Indolent CD4+ CAR T-Cell Lymphoma after Cilta-cel CAR T-Cell Therapy

The second study pertains to patients treated with CAR-T cells at the Stanford University Medical Center in California between 2016 and 2024. Out of 724 treated patients, 25 developed secondary tumors, including 14 hematologic (13 myelodysplastic syndromes or acute myeloid leukemias and one T-cell lymphoma) and 11 solid tumors (four melanomas, two prostate carcinomas, one endometrial adenocarcinoma, one lung adenocarcinoma, and one metastatic mesothelioma). The cumulative incidence of secondary tumors at 3 years was low (6.5%).

Read: Risk of Second Tumors and T-Cell Lymphoma after CAR T-Cell Therapy



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