Roche Receives FDA Approval for Columvi in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Roche today announced that the FDA has granted accelerated approval to Columvi (glofitamab-gxbm) for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from follicular lymphoma, after two or more prior lines of systemic therapy. Columvi is a CD20xCD3 bispecific antibody that redirects T cells to kill CD20-positive B-cell lymphoma cells. In the NP30179 trial, Columvi demonstrated a complete response rate of 39.4% in heavily pretreated patients. The fixed-duration treatment course of 12 cycles is a unique feature of Columvi that distinguishes it from other therapies.