Benzinga | Jan 28, 2022 07:00AM EST

Bristol Myers Squibb Receives Positive CHMP Opinion For CAR T Cell Therapy Breyanzi For Relapsed Or Refractory DLBCL, PMBCL And FL3B

Bristol Myers Squibb (NYSE:BMY) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of 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 (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B) after two or more lines of systemic therapy. The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).

"This positive CHMP opinion is an important milestone that recognizes Breyanzi as a differentiated cell therapy with the potential to address unmet needs for patients in the European Union with aggressive lymphomas who have limited treatment options," said Anne Kerber, senior vice president, Cellular Therapy Development, Bristol Myers Squibb. "We look forward to the European Commission's decision as we continue to accelerate our research in cell therapy to develop new treatment options for patients living with difficult-to-treat blood cancers."

The CHMP adopted a positive opinion based on results from TRANSCEND NHL 001, the largest pivotal trial of patients with R/R LBCL after at least two prior therapies, and additional data from the TRANSCEND WORLD study. The studies evaluated patients with R/R DLBCL, PMBCL and FL3B, including those with a broad range of histologies and high-risk disease, and patients who received Breyanzi in the inpatient and outpatient setting.

The EC is expected to deliver its final decision within 67 days of receipt of the CHMP opinion. The decision will be applicable to all European Union member states and Iceland, Norway and Liechtenstein.*

*Centralized Marketing Authorization does not include approval in Great Britain (England, Scotland and Wales).