Posted by Michael Wonder on 19 Jun 2026
FDA accepts supplemental biologics license application for Roche’s Lunsumio and Polivy combination for people with relapsed or refractory large B-cell lymphoma
18 June 2026 - Roche announced today that the US FDA has accepted the company’s supplemental biologics license application for Lunsumio Velo (mosunetuzumab), as a subcutaneous formulation, in combination with Polivy (polatuzumab vedotin) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, after at least one prior line of systemic therapy.
The FDA is expected to make a decision on approval by 9 February 2027.
