Lisocabtagene maraleucel receives a positive opinion from the EMA CHMP for the treatment of R/R DLBCL, PMBCL, and FL

On January 31, 2022, it was announced that lisocabtagene maraleucel (liso-cel) received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B after two or more lines of systemic therapy. The decision was based on results from TRANSCEND NHL 001 (NCT02631044), the largest pivotal trial of patients with large B-cell lymphoma (LBCL), and additional data from the TRANSCEND WORLD (2017-000106-38) study. The TRANSCEND trials evaluated patients with a broad range of histologies and high-risk disease who were treated in inpatient and outpatient settings.

Currently, the CHMP recommendation is being reviewed by the European Commission, which has the authority to approve medicines for the European Union. The European Commission is expected to reach its final decision within 67 days of receiving the CHMP opinion, this will be applicable to all European Union member states including Iceland, Norway, and Liechtenstein.

About liso-cel

Liso-cel is a CD19-directed chimeric antigen receptor (CAR) T-cell therapy with a defined composition, designed to reduce variability of the CD8 and CD4 component dose, and a 4-1BB signaling domain to enhance the expansion and persistence of the CAR T cells.

The cell therapy has recently been approved by the U.S. Food and Drug Administration (FDA) and in Japan for the treatment of patients with relapsed/refractory LBCL and follicular lymphoma grade 3B after ≥2 lines of therapy.