Roche announced that the FDA's Oncologic Drugs Advisory Committee discussed the supplemental Biologics License Application for Columvi in combination with gemcitabine and oxaliplatin for the treatment of people with relapsed or refractory diffuse large B-cell lymphoma. Columvi demonstrated a 41% reduction in risk of death in a phase III randomized clinical trial, supporting its recent approval by the European Commission and inclusion in the US National Comprehensive Cancer Network treatment guidelines as a category 1 preferred regimen. The committee discussed the applicability of the phase III STARGLO results to the US patient population, with members citing that further data are needed. The STARGLO study enrolled 274 patients globally across 62 sites in 13 countries, with the majority of patients enrolling outside of Asia. The clinical and disease characteristics of the overall population enrolled in this multiregional clinical trial are representative of US patients with this disease today. A statistically significant 41% reduction in the risk of death was observed in patients treated with Columvi in combination with gemcitabine and oxaliplatin versus rituximab plus gemcitabine and oxaliplatin. The Columvi combination also met its key secondary endpoints, with a 63% reduction in risk of disease worsening or death compared to rituximab plus gemcitabine and oxaliplatin. The safety of the combination was consistent with the known safety profiles of the individual medicines. The FDA's evaluation of this Columvi combination for relapsed or refractory diffuse large B-cell lymphoma is ongoing, and a decision on approval is expected by July 20, 2025.