The US FDA has accepted Roche's supplemental Biologics License Application for Lunsumio VELO in combination with Polivy. This submission is for adult patients with relapsed or refractory large B-cell lymphoma (LBCL). The application is supported by data from the phase III SUNMO study. This combination demonstrated a significant 59% reduction in the risk of disease progression or death versus the R-GemOx regimen. Median progression-free survival was substantially longer with Lunsumio VELO and Polivy at 11.5 months compared to 3.8 months for R-GemOx. The safety profile of the combination was consistent with individual drug profiles, and cytokine release syndrome events were low. If approved, this outpatient-ready regimen could improve access to care in community settings. Relapsed or refractory LBCL represents a high unmet need in lymphoma treatment. The development signifies a potential important chemotherapy-free option for these patients. The FDA is expected to decide on approval by February 9, 2027.