Roche Receives FDA Regular Approval for Columvi in Diffuse Large B-Cell Lymphoma

Roche today announced that the FDA has granted regular 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. This regular approval converts the prior accelerated approval of Columvi and is based on updated data from the NP30179 trial showing durable responses. The updated data showed a complete response rate of 39.4% with a median duration of complete response of 34.4 months. These results confirm the durable clinical benefit of Columvi in relapsed or refractory DLBCL.