FDA Accepts sBLA for Roche's Lunsumio VELO and Polivy Combination in Relapsed or Refractory Large B-Cell Lymphoma

The FDA has accepted Roche's supplemental Biologics License Application (sBLA) for Lunsumio VELO (mosunetuzumab), a subcutaneous CD20xCD3 bispecific antibody, in combination with Polivy (polatuzumab vedotin) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), after at least one prior line of systemic therapy. This acceptance is based on data from the phase III SUNMO study, which showed a 59% reduction in the risk of disease progression or death and a more than three-times longer median progression-free survival (11.5 months versus 3.8 months) compared with R-GemOx. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of February 9, 2027, for its decision on the sBLA. Lunsumio VELO is already FDA-approved as a subcutaneous formulation for adult patients with relapsed or refractory follicular lymphoma after two or more prior therapies.