Posted by Michael Wonder on 17 Jul 2020
EMA validates Bristol Myers Squibb’s application for CAR T cell therapy lisocabtagene maraleucel
17 July 2020 - Application based on positive results from TRANSCEND NHL 001 study and additional TRANSCEND WORLD 001 study.
Bristol Myers Squibb today announced that the EMA has validated its marketing authorisation application for lisocabtagene maraleucel, an investigational CD19-directed chimeric antigen receptor T cell therapy, for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma and follicular lymphoma grade 3B after at least two prior therapies.
Validation of the application confirms the submission is complete and begins the EMA’s centralised review process.
