FDA Accepts Roche's (RHHBY) sBLA for Lunsumio-Polivy in Untreated DLBCL

Genentech, a member of the Roche Group (RHHBY), announced on June 18, 2026, that the U.S. Food and Drug Administration (FDA) accepted its supplemental Biologics License Application (sBLA) for the Lunsumio (mosunetuzumab) and Polivy (polatuzumab vedotin) combination. The sBLA seeks approval for the first-line treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of February 2027 for the decision. This application is supported by data from the Phase III CELESTIMO study, which evaluated the efficacy and safety of the combination therapy. Lunsumio is a CD20xCD3 T-cell engaging bispecific antibody, while Polivy is an antibody-drug conjugate.