The European Commission expanded approval of the CD19-directed chimeric antigen receptor T-cell therapy lisocabtagene maraleucel (liso-cel; Breyanzi®) in patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy.
The approval of the expanded indication is based on results from the TRANSCEND MCL trial, in which 82.7% of patients responded to liso-cel, with 71.6% of patients achieving complete response, according to BMS, the manufacturer of liso-cel.
Liso cel demonstrated sustained clinical benefit, BMS reported, with 50.8% of patients still in response at 24 months based on TRANSCEND MCL trial results.
The expanded approval is applicable to all European Union member states as well as the European Economic Area countries Iceland, Norway and Liechtenstein. Liso-cel is also approved in the EU for diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma.
