18/06/2026 US FDA accepts Roche’s sBLA for subcutaneous Lunsumio + Polivy in relapsed/refractory LBCL US FDA accepts Roche’s sBLA for subcutaneous Lunsumio + Polivy in relapsed/refractory LBCL (Ref) The US FDA has accepted Roche’s supplemental Biologics License Application (sBLA) for subcutaneous Lunsumio VELO (mosunetuzumab; CD20xCD3 T-cell engaging bispecific antibody) + Polivy (polatuzumab vedotin; CD79b targeting antibody-drug conjugate) in adults with relapsed/refractory

22/12/2025 Roche's mosunetuzumab SC received the FDA accelerated approval for follicular lymphoma AstraZeneca and Daiichi Sankyo’s trastuzumab deruxtecan received the FDA breakthrough therapy designation for early breast cancer AstraZeneca's ceralasertib + durvalumab failed to meet the OS endpoint in PD(L)-1 failed NSCLC Roche's mosunetuzumab SC received the FDA accelerated approval for follicular lymphoma (Ref) The US FDA granted accelerated approval to Roche's Lunsumio VELO