FDA accepts Roche’s sBLA for Lunsumio and Polivy combo
The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Lunsumio VELO (mosunetuzumab), as a subcutaneous formulation, in combination with Polivy (polatuzumab vedotin), Swiss pharma giant Roche (ROG: SIX) announced today.
This is a 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. The FDA is expected to make a decision on approval by 9 February 2027.
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