Bristol Myers Squibb gets European Commission nod for Breyanzi for follicular lymphoma

“This additional approval for Breyanzi in FL represents a critical step forward in our mission to deliver on the transformational promise of cell therapy for more patients across Europe,” said Emma Charles, senior vice president, Europe Region, Bristol Myers Squibb. “While significant advancements have been made in the last two decades, there still remains unmet need for patients. Newer treatments for FL, like Breyanzi , have shown impactful results in clinical trials, with the opportunity to deliver lasting results in the routine care setting.”

The decision is based on results from the global, Phase 2 TRANSCEND FL study, the largest clinical trial to date to evaluate a CAR T cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma (NHL), including FL. Among patients treated in the third-line plus setting, Breyanzi demonstrated a high overall response rate of 97.1% (95% CI: 91.7–99.4) and complete response (CR) rate of 94.2% (95% CI: 87.8–97.8), the study’s primary and key secondary endpoints, respectively. Responses were rapid, durable and demonstrated sustained efficacy, with a median time to first response of 0.95 months (range: 0.6 to 3.3 months) and 75.7% (95% CI: 66.0–83.0) of patients still in response at 18 months.

Safety results were consistent with the well-established safety profile of Breyanzi observed across clinical trials and approved indications, with no new safety signals observed in FL. In all patients treated in the TRANSCEND FL study (second-line plus), any grade cytokine release syndrome (CRS) occurred in 58% of patients, with only 0.8% of patients experiencing Grade 3 CRS. The median time to onset was 6 days (range: 1 to 17 days). Any grade neurologic toxicities occurred in 16% of patients, including Grade 3 in 3% of patients. The median time to onset of the first event was 8 days (range: 4 to 16 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 FL 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.

Follicular lymphoma (FL) is the second most common form of NHL, accounting for 20-30% of all NHL cases. FL develops when white blood cells cluster together to form lumps in a person’s lymph nodes or organs. FL is an incurable disease, with patients frequently relapsing following front-line therapy and prognosis worsening after each subsequent relapse. Despite advances in treatment, there remains an unmet need for additional options for relapsed or refractory FL that offer treatment-free intervals with durable, complete responses.

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