EC Approves for Liso-cel for Follicular Lymphoma
March 17, 2025
The European Commission (EC) recently
approved Bristol Myers Squibb’s 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 approval expands the availability of liso-cel across all European Union member states and European Economic Area countries.
The agency based its approval on results from the
phase 2 TRANSCEND FL study, the largest clinical trial to date evaluating CAR T-cell therapy in relapsed or refractory indolent non-Hodgkin lymphoma, including FL. The study demonstrated an overall response rate of 97.1%, with 94.2% of patients achieving complete response. At 18 months, 75.7% of patients remained in response. Liso-cel also showed a consistent safety profile, with no new safety signals observed.
This approval adds to liso-cel existing indications in the EU for relapsed or refractory diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and FL grade 3B.
