The drug is intended to treat relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B) in adult patients after two or more lines of systemic therapies.
A CD19-directed chimeric antigen receptor (CAR) T cell therapy, Breyanzi has a defined composition and 4-1BB costimulatory domain.
The drug is given as a defined composition to minimise the variability of the CD8 and CD4 component dose.
The European Commission is expected to provide its final decision of Breyanzi within 67 days of receipt of the CHMP opinion.
The company stated that the EU’s decision will be applicable to all European Union member states and Norway, Liechtenstein, and Iceland.
Bristol Myers Squibb cellular therapy development senior vice president Anne Kerber said: “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.
“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 regulator’s positive opinion was based on the data obtained from TRANSCEND NHL 001 and the TRANSCEND WORLD trials.
Conducted in the US, the multicentre, open-label, pivotal TRANSCEND NHL 001 trial evaluated Breyanzi’s safety, pharmacokinetics, and antitumor activity in R/R LBCL, DLBCL, high-grade B-cell lymphoma (HGL), FL3B, and PMBCL patients.
The TRANSCEND WORLD trial evaluated the drug’s efficacy and safety in aggressive B-cell non-Hodgkin lymphoma (NHL) patients.