FDA grants RMAT to CAR-T therapy P-BCMA-ALL01 for relapsed/refractory multiple myeloma with 82% response rate.
The FDA has awarded RMAT designation to P-BCMA-ALL01, an investigational CAR-T therapy for relapsed/refractory multiple myeloma, based on early trial data showing an 82% overall response rate. The therapy demonstrated no graft-vs-host disease and low rates of CRS and neurotoxicity. Additionally, insights from experts at ESMO 2024 highlight advancements in CAR-T and bispecific therapies, offering new hope for patients with limited treatment options.
September 17, 2024
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