NEW YORK – The European Commission on Tuesday granted marketing authorization to Bristol Myers Squibb's CD19-directed CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) for the treatment of relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B after two or more lines of systemic therapy.
The approval was based on data from the Phase I TRANSCEND NHL 001 study that evaluated Breyanzi in patients with the three lymphoma types. Across 216 patients, the response rate was 73 percent, with about half reaching minimal or no detectable lymphoma remaining following treatment. In all responders, the median duration of response was 20.2 months, and in patients who achieved a complete response, the median duration of response was 26.1 months.
BMS submitted pooled safety data from four studies, including TRANSCEND NHL 001. Among 314 diffuse large B-cell lymphoma patients treated with Breyanzi in those trials, 39 percent of patients experienced any grade cytokine release syndrome.
"Breyanzi addresses an ongoing unmet need for patients in Europe battling relapsed or refractory large B-cell lymphoma who have few treatment options that provide long-term remission," BMS Chief Medical Officer Samit Hirawat said in a statement. "The EC approval of Breyanzi is a significant step towards bringing the novel and personalized science of CAR T cell therapies to more patients around the world."
Last year, the US Food and Drug Administration approved Breyanzi as a treatment for relapsed or refractory large B-cell lymphoma patients who have received at least two other systemic treatments.
This is Breyanzi's first approval in Europe. BMS' other CAR T-cell therapy, Abecma (idecabtagene vicleucel), has conditional approval in Europe as a therapy for heavily pretreated patients with relapsed and refractory multiple myeloma.