NEW YORK – Bristol Myers Squibb on Wednesday said the European Commission has approved the autologous CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) as a second-line option for relapsed or refractory large B-cell lymphoma patients.
The approval follows a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in March and is based on the results of the Phase III TRANSFORM clinical trial. In TRANSFORM, Breyanzi improved patients' event-free survival outcomes versus standard second-line therapy. The approval makes Breyanzi available to EU patients with diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma, whose cancers relapsed within a year of first-line chemo-immunotherapy.
The US Food and Drug Administration approved Breyanzi for this second-line lymphoma indication in June 2022.
Breyanzi's main competitor, Gilead Sciences' Yescarta (axicabtagene ciloleucel), is also approved as a second-line lymphoma treatment in the US and EU.
"With Breyanzi, people in Europe living with relapsed or refractory DLBCL now have a differentiated CAR T-cell therapy option earlier in the treatment paradigm that provides long-term clinical benefit," Anne Kerber, BMS's senior VP and head of cell therapy development, said in a statement.