Roche's (RHHBY.US) new indication application for its CD20/CD3 dual antibody was accepted by FDA

Roche (RHHBY.US) announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for glofitamab, in combination with gemcitabine and oxaliplatin (GemOx regimen), for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who have received at least one prior therapy and are ineligible for autologous stem cell transplant. The FDA is expected to make a decision on the application by July 20, 2025.

Based on the III phase STARGLO study, glofitamab in combination with GemOx showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared to R-GemOx. In the preliminary analysis (median follow-up of 11.3 months), glofitamab reduced the risk of death by 41% (HR=0.59).

According to public information, glofitamab is a bispecific antibody that can simultaneously target CD3 on the surface of T cells and CD20 on the surface of B cells, belonging to the T cell engager (TCE) type of bispecific antibodies. Glofitamab activates T cells by bringing them close to B cells through binding to CD3 and CD20, and releases cytotoxic proteins such as perforin to kill pathogenic B cells and exert antitumor effects. Previously, glofitamab was approved by the FDA for the treatment of adult patients with R/R DLBCL or follicular lymphoma (FL) who have received at least two prior systemic therapies.