Bristol Myers Squibb gets European Commission nod for Breyanzi for follicular lymphoma
Princeton: Bristol Myers Squibb has announced that the European Commission (EC) has granted approval to Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
“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.
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