Roche Chemo-Free Lymphoma Combo Gains FDA Review, Cutting Risk by 59%

The U.S. Food and Drug Administration (FDA) accepted Roche’s supplemental Biologics License Application for the combination of Lunsumio and Polivy. This application targets adult patients with relapsed or refractory large B-cell lymphoma. Eligible patients must have completed at least one prior line of therapy. The agency expects to issue a decision by February 9, 2027.

Results from the Phase III SUNMO study support the submission. The combination therapy reduced the risk of disease progression or death by 59% compared to the standard of care. The Lunsumio and Polivy regimen demonstrated a median progression-free survival of 11.5 months. The control group recorded a median progression-free survival of 3.8 months.

If approved, this subcutaneous, chemotherapy-free regimen will provide a new outpatient-ready option. The treatment addresses a patient population with significant unmet medical needs.