Roche Receives FDA Approval for Columvi Plus Ibrutinib in Relapsed/Refractory CLL

Roche today announced that the FDA has approved Columvi (glofitamab-gxbm) plus ibrutinib for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia. In the Phase 3 GLOW trial, Columvi plus ibrutinib demonstrated a statistically significant improvement in progression-free survival versus ibrutinib alone. This approval provides CLL patients with a new combination treatment option combining bispecific antibody and BTK inhibitor therapy. Columvi is a bispecific antibody targeting CD20 and CD3.