Roche announced that the U.S. Food and Drug Administration (FDA) has approved Columvi (glofitamab-gxbm) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.

This indication is approved under accelerated approval based on response rate and durability of response in the phase I/II NP30179 study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Columvi will be available in the US in the coming weeks.

“People with diffuse large B-cell lymphoma who have gone through multiple lines of therapy have a poor prognosis and desperately need additional treatment options,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “As an off-the-shelf, fixed-duration treatment providing durable response rates, we believe Columvi could change the way this aggressive lymphoma is treated, reinforcing our dedication to bringing innovative treatment options to people with critical unmet needs.”

DLBCL is an aggressive, hard-to-treat disease and is the most common form of non-Hodgkin lymphoma in the US.2 While many people with DLBCL are responsive to treatment, the majority of those who relapse or are refractory to subsequent treatments have poor outcomes.3,4

“Patients with relapsed or refractory diffuse large B-cell lymphoma may experience rapid progression of their cancer and often urgently need an effective treatment option that can be administered without delay,” said Krish Patel, M.D., Director of the Lymphoma Program at the Swedish Cancer Institute in Seattle and investigator of the Columvi phase I/II NP30179 study. “Experience from clinical trials demonstrates that Columvi can provide patients with relapsed or refractory diffuse large B-cell lymphoma a chance for complete remission with a fixed duration immunotherapy and that such remissions can potentially be sustained after the end of their treatment.” 

Columvi is the first and only CD20xCD3 T-cell engaging bispecific antibody for the treatment of R/R DLBCL that is given for a defined period of time, unlike treat-to-progression approaches where treatment is given indefinitely until the cancer progresses or the therapy cannot be tolerated, whichever occurs first. Designed to be completed in approximately 8.5 months, Columvi offers people with R/R DLBCL a target end date for their course of treatment and the possibility of a treatment-free period. Additionally, Columvi is a chemotherapy-free treatment option that is off-the-shelf and ready for infusion.