Another first-in-class to receive FDA approval was Axicabtagene ciloleucel, the first anti-CD19 CAR-T cell product to be approved for the treatment of adult patients with aggressive r/r B-NHL, including r/r DLBCL, transformed follicular lymphoma and primary mediastinal B-cell lymphoma [1...
with high levels of morbidity and mortality, especially considering patients who manifest multiple refractory diseases. Recently, (CAR-T cell therapy has emerged as a potential therapeutic option for r/r B cell malignancies, which have motivated the FDA approval of a series of products based...
All of these CAR T cells are genetically modified cells and, as part of the approval process, the FDA mandated that the sponsors, or the industry, develop an infrastructure to follow these patients long-term. The concern is that these patients may develop second malignancies in the p...