European Commission approves Bristol Myers Squibb’s Breyanzi for Relapsed or Refractory Follicular Lymphoma
March 14, 2025The 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, Bristol Myers Squibb said Friday.
Emma Charles, senior vice president, Europe Region, BMS said that 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, Charles was quoted as saying in a press release
According to BMS’s announcement, 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.
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, the company said.
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.