NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday issued a positive opinion recommending BMS' autologous, CD19-directed CAR T-cell therapy lisocabtagene maraleucel (Breyanzi; liso-cel) for patients with several types of advanced lymphoma.
CHMP recommended liso-cel for patients in the EU with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B after two or more systemic therapies.
The European Commission will now review CHMP's opinion and in about two months decide whether to approve BMS' autologous cell therapy.
CHMP's positive opinion is rooted in results from the US-based Phase I TRANSCEND NHL 001 trial of third-line liso-cel in relapsed or refractory lymphoma patients, as well as the Phase II TRANSCEND WORLD study of liso-cel in aggressive B-cell non-Hodgkin lymphoma patients in Japan and Europe.
The US Food and Drug Administration approved liso-cel for relapsed or refractory LBCL patients last February.