Bristol Myers Squibb (BMS) has received the European Commission (EC) expanded approval for Breyanzi (lisocabtagene maraleucel; liso-cel) to treat adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
Breyanzi is a CD19-directed chimeric antigen receptor (CAR) T cell therapy designed to enhance the expansion and persistence of CAR T cells, providing a one-time treatment option.
The drug is previously approved in the European Union (EU) for diffuse large B-cell lymphoma and high-grade B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and FL grade 3B (FL3B).
The expanded approval applies to all EU member states and European Economic Area countries, including Iceland, Liechtenstein, and Norway.
Breyanzi is also approved in Canada, Japan, Switzerland, the UK, and the US, in several indications.
Bristol Myers Squibb Europe Region senior vice president Emma Charles said: “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.
“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 EC expanded approval was informed by the Phase 2 TRANSCEND FL study, which assessed the efficacy and safety of Breyanzi in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including FL.
In the study, Breyanzi resulted in a high overall response rate of 97.1% and a complete response (CR) rate of 94.2%, showing rapid and durable responses.
The drug’s safety results were consistent with its established profile, with no new safety signals identified.
The trial used the Lugano criteria (2014) for assessing complete response via PET-CT.
However, the US Food and Drug Administration required additional bone marrow biopsies for CR evaluation, which caused discrepancies in response rates between the EU and the US.
