EMA validates B-MS' application for CAR T cell therapy
US pharma major Bristol-Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency has validated its Marketing Authorization Application (MAA) for lisocabtagene maraleucel (liso-cel).
The drug is an investigational CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B) after at least two prior therapies.
Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.
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