European Commission approves R... Note

European Commission approves Roche’s Columvi as the first bispecific antibody for diffuse large B-cell lymphoma after initial therapy

Roche announced European Commission approval for Columvi (glofitamab) combined with chemotherapy to treat adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This combination is the first bispecific antibody regimen available for this patient population in Europe, offering a new treatment option. Approval is based on the Phase III STARGLO study which showed a 41% reduction in the risk of death with Columvi plus chemotherapy compared to rituximab plus chemotherapy. The Columvi combination also significantly improved progression-free survival and complete response rates. DLBCL is an aggressive blood cancer where around 40% of patients relapse after initial treatment. This "off-the-shelf" treatment can be readily available, offering a fixed-duration course. Columvi is part of Roche's CD20xCD3 bispecific antibody program with the goal of offering tailored therapies. Roche is also investigating Columvi in earlier stages of DLBCL. The STARGLO study demonstrated the efficacy and safety of the Columvi regimen. Columvi is designed to target CD3 on T cells and CD20 on B cells to kill cancer cells.