FDA Approves Obe-cel for ALL

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The FDA has approved obecabtagene autoleucel (obe-cel) for relapsed or refractory adult B-cell acute lymphoblastic leukemia based on efficacy and safety findings from the FELIX study. The treatment showed a CR/CRi rate of 77% and a CR rate of 57% with minimal residual disease negativity in 96% of patients. Low rates of severe cytokine release syndrome and neurotoxicity were reported. Obe-cel benefited patients with low leukemia burden, with high response rates and minimal toxicities. Ongoing CAR T cell persistence and B-cell aplasia were associated with improved event-free survival. Overall survival rates were promising. Experts are optimistic about the potential of obe-cel in reducing CAR T cell toxicity.

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