Roche Group member Genentech has secured approval from the US Food and Drug Administration (FDA) for its Columvi (glofitamab-gxbm) to treat adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
The approval has been granted for patients with R/R DLBCL not otherwise specified or large B-cell lymphoma (LBCL) caused by follicular lymphoma, after two or more systemic therapy lines.
It is based on accelerated approval supported by the durability of response and response rate in the Phase I/II NP30179 trial.
Sustained approval for this indication may depend upon validation and description of clinical benefit in a confirmatory study.
Columvi will be available in the US later this year.
It is a CD20xCD3 T-cell engaging bispecific antibody designed to treat R/R DLBCL, and is given for a specific time period.
Treatment with Columvi eliminates the treat-to-progression approach, in which the patient is treated indefinitely until their cancer grows or the therapy cannot be tolerated.
Columvi is given in 13 intravenous infusions for a maximum of 12 cycles, including step-up dosing, or until disease progression or intolerability of the treatment, whichever happens first.
The therapy is part of Genentech’s T-cell-engaging bispecific antibodies portfolio in non-Hodgkin’s lymphoma, which also features the newly approved Lunsumio for the treatment of follicular lymphoma.
Roche chief medical officer and global product development head Levi Garraway stated: “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.
“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.”