The United States Food and Drug Administration has accepted a supplemental Biologics License Application for mosunetuzumab (Lunsumio VELO) in combination with polatuzumab vedotin (Polivy) to treat adults with relapsed or refractory large B-cell lymphoma who have received at least one prior systemic therapy.
The submission is supported by findings from the phase 3 SUNMO trial evaluating the subcutaneous formulation of mosunetuzumab alongside intravenous polatuzumab vedotin for patients who are ineligible for an autologous stem cell transplant.
Mosunetuzumab is a bispecific antibody designed to target CD20 and CD3, while polatuzumab vedotin is an antibody-drug conjugate that targets CD79b to deliver a cytotoxic agent directly into lymphoma cells.
According to a press release by Roche, the manufacturer of the drug, this investigational combination reduced the risk of disease progression or death and prolonged progression-free survival compared to a standard regimen of rituximab, gemcitabine, and oxaliplatin.
The FDA is anticipated to issue an approval decision by February 9, 2027.
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