Roche：Lunsumio VELO™Mosunetuzumab marketing application submitted
On June 18 local time, Roche announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Lunsumio VELO™ (mosunetuzumab), a subcutaneous formulation, 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), who have received at least one prior line of systemic therapy. The FDA is expected to make an approval decision by February 9, 2027.
The sBLA acceptance is based on results from the Phase III SUNMO study. At a median follow-up of 23.2 months, compared with the R-GemOx regimen (rituximab, gemcitabine, and oxaliplatin), the Lunsumio VELO plus Polivy combination demonstrated a 59% reduction in the risk of disease progression or death (HR 0.41, p<0.0001), with a median PFS of 11.5 months—three times longer than the 3.8 months observed with R-GemOx.
The safety profile of the Lunsumio plus Polivy combination was consistent with the known safety profiles of the individual drugs. The incidence of cytokine release syndrome (CRS) in the Lunsumio VELO plus Polivy arm was low, occurring in approximately one in four patients, with less than 5% of patients experiencing Grade 2 or 3 CRS. Updated data from the trial were recently presented at ASCO and EHA congresses, showing that with extended follow-up, the combination continued to demonstrate clinical benefit in progression-free survival, particularly in the second-line setting, with no new safety signals identified.
Lunsumio (mosunetuzumab) is a first-in-class CD20×CD3 T-cell engaging bispecific antibody, currently approved for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received three or more prior lines of therapy, available in both intravenous and subcutaneous (Lunsumio VELO™) formulations.
Polivy (polatuzumab vedotin) is a first-in-class CD79b-directed ADC, widely approved globally for use in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone for the treatment of previously untreated (first-line) DLBCL, as well as in combination with bendamustine and rituximab for relapsed or refractory DLBCL. In 2025, the drug achieved annual sales of $1.777 billion.
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