Bristol Myers Squibb Breyanzi secures European Commission nod for Mantle Cell Lymphoma

“This approval for Breyanzi in relapsed or refractory mantle cell lymphoma marks another important step as we continue to deliver on the promise of cell therapy for more eligible patients across Europe – the fourth approval for Breyanzi in Europe,” said Emma Charles, senior vice president, Europe Region, Bristol Myers Squibb. “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. Breyanzi has the opportunity to address a treatment gap for this patient population based on its demonstrated clinical benefit.”

The decision is 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 inhibitor. Among patients treated in the third-line plus setting, Breyanzi demonstrated a high overall response rate of 82.7% (95% CI: 72.7–90.2) and complete response (CR) rate of 71.6% (95% CI: 60.5–81.1), the study’s primary and key secondary endpoints, respectively. Responses were rapid and demonstrated sustained efficacy, with a median time to first response (CR or partial response (PR)) of 0.95 months (range: 0.7 to 3.0 months) and 50.8% (95% CI: 29.2–52.9) of patients still in response at 24 months.

Safety results were consistent with the well-established safety profile of Breyanzi observed across clinical trials and approved indications, with a predictable safety profile observed in MCL with early resolution. The majority of cytokine release syndrome (CRS) and neurologic toxicities developed during the first 14 days post infusion, reinforcing recent adjustments to short term monitoring requirements. For patients who received Breyanzi for MCL in the TRANSCEND NHL 001 trial, CRS occurred in 61% of patients, with only 1% of patients 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. The median time to onset of the first event was eight days (range: 1 to 25 days).

This expanded approval is applicable to all European Union (EU) member states as well as the European Economic Area (EEA) countries Iceland, Norway and Liechtenstein. Breyanzi is also approved in the EU for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy, and for the treatment of adult patients with relapsed or refractory DLBCL, PMBCL, and FL3B after two or more lines of systemic therapy, and for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.