
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of lisocabtagene maraleucel (liso-cel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.1 The European Commission is expected to issue a final decision approximately two months following the announcement of the positive CHMP opinion.
The positive opinion is based on results from the phase II TRANSCEND FL study, in which liso-cel, a CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy, demonstrated an overall response rate of 97.1% (95% CI, 91.7%-99.4%) and a complete response rate of 94.2% (95% CI, 87.8%-97.8%). Efficacy was sustained at 18 months in 75.7% of patients who responded (95% CI, 66.0%-83.0%).1 More than half (58%) of patients experienced cytokine release syndrome, and 15% experienced neurologic events.2
Liso-cel previously received accelerated approval from the FDA in May 2024 for adult patients with relapsed or refractory FL who received two or more prior lines of systemic therapy.3 The CAR-T therapy is also approved in the United States for large B-cell lymphoma and relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after two or more lines of therapy.
Read More: Liso-Cel Approved by FDA for CLL, SLL
References
- Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma. Business Wire. January 31, 2025. Accessed February 5, 2025. https://www.businesswire.com/news/home/20250129665217/en/Bristol-Myers-Squibb-Receives-Positive-CHMP-Opinion-for-CAR-T-Cell-Therapy-Breyanzi-for-Relapsed-or-Refractory-Follicular-Lymphoma
- Morschhauser F, Dahiya S, Palomba ML, et al. Lisocabtagene maraleucel in follicular lymphoma: the phase 2 TRANSCEND FL study. Nat Med. 2024;30(8):2199-2207. doi:10.1038/s41591-024-02986-9
- FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma. US Food and Drug Administration. May 15, 2024. Accessed February 5, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-lisocabtagene-maraleucel-follicular-lymphoma