Bristol Myers Squibb Receives European Commission Approval for Breyanzi in Relapsed/Refractory Mantle Cell Lymphoma
核心洞察
The European Commission approved Breyanzi (lisocabtagene maraleucel) for treating adult patients with relapsed or refractory mantle cell lymphoma (搜索) after at least two prior therapies including a BTK (搜索) inhibitor.
In the TRANSCEND MCL trial, 82.7% of patients responded to Breyanzi with 71.6% achieving complete response, and 50.8% remained in response at 24 months.
This marks the fourth European approval for Breyanzi, expanding treatment options for patients with this rare but aggressive form of non-Hodgkin lymphoma (搜索).
Bristol Myers Squibb (搜索) announced that the European Commission has granted approval for Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19 (搜索)-directed chimeric antigen receptor (CAR) T cell therapy, for treating adult patients with relapsed or refractory mantle cell lymphoma (搜索) (MCL) after at least two lines of systemic therapy including a Bruton's tyrosine kinase (搜索) (BTK (搜索)) inhibitor.
This approval represents the fourth European authorization for Breyanzi and addresses a critical treatment gap for patients with this rare but aggressive form of non-Hodgkin lymphoma (搜索). "While frontline therapies have advanced over the years for this rare but aggressive form of non-Hodgkin lymphoma, the vast majority of patients relapse or become resistant and face reduced survival outlook, leaving a critical need for new treatment options," said Emma Charles, senior vice president, Europe Region, Bristol Myers Squibb (搜索).
Clinical Trial Results Drive Approval Decision
The European Commission's decision was based on results from the MCL cohort of TRANSCEND NHL 001, which enrolled adult patients with relapsed or refractory MCL who had received at least two prior lines of therapy including a BTK (搜索) inhibitor. Among patients treated in the third-line plus setting, Breyanzi demonstrated impressive efficacy outcomes.
The therapy achieved a high overall response rate of 82.7% (95% CI: 72.7–90.2) and complete response rate of 71.6% (95% CI: 60.5–81.1), meeting the study's primary and key secondary endpoints, respectively. Responses were rapid, with a median time to first response of 0.95 months (range: 0.7 to 3.0 months).
Notably, the treatment showed sustained clinical benefit, with 50.8% (95% CI: 29.2–52.9) of patients still in response at 24 months, demonstrating the durability of the therapeutic effect.
Safety Profile Remains Manageable
Safety results were consistent with Breyanzi's well-established profile across clinical trials and approved indications. The majority of cytokine release syndrome (搜索) (CRS) and neurologic toxicities developed during the first 14 days post-infusion, with early resolution observed.
For patients who received Breyanzi for MCL in the TRANSCEND NHL 001 trial, CRS occurred in 61% of patients, with only 1% experiencing grade three or four CRS. The median time to onset was four days (range: 1 to 10 days). Any grade neurologic toxicities occurred in 31% of patients, including grade three or four in 9% of patients, with a median time to onset of eight days (range: 1 to 25 days).
Expanding Treatment Landscape
This expanded approval applies to all European Union member states as well as the European Economic Area countries Iceland, Norway and Liechtenstein. Breyanzi is already approved in the EU for treating various B-cell lymphomas, including diffuse large B-cell lymphoma (搜索), high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma under specific clinical circumstances.
About Mantle Cell Lymphoma and Breyanzi
Mantle cell lymphoma (搜索) represents roughly 3% of all non-Hodgkin lymphoma (搜索) cases and is an aggressive, rare form that originates from cells in the "mantle zone" of the lymph node. The disease occurs more frequently in older adults with an average age at diagnosis in the mid-60s and is more often found in males than females. Relapse after initial treatment is common, and for most patients, the disease eventually progresses or returns.
Breyanzi is a CD19 (搜索)-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. The therapy is manufactured from a patient's own T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment.