CHMP recommends approval of Breyanzi for diffuse large B-cell lymphoma, mediastinal large B-cell lymphoma and follicular lymphoma grade 3B.- BMS

The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).

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.

Comment: TRANSCEND NHL 001 is an open-label, multicenter, pivotal Phase I study conducted in the US to determine the safety, antitumor activity and pharmacokinetics of Breyanzi in patients with R/R LBCL, including DLBCL, high-grade B-cell lymphoma (HGL), PMBCL and FL3B. The primary outcome measures included treatment-related adverse events, dose-limiting toxicities and objective response rate. Key secondary outcome measures included complete response rate, duration of response, progression-free survival and overall survival. TRANSCEND WORLD is a single-arm, multi-cohort, multicenter, Phase II study to determine the efficacy and safety of Breyanzi in patients with aggressive B-cell non-Hodgkin lymphoma (NHL). The primary outcome measure was overall response rate. Secondary outcome measures included safety, complete response rate, event-free survival, progression-free survival, overall survival, duration of response, pharmacokinetics and health-related quality of life. The study was conducted in Europe and Japan.