FDA Approves Genentech’s Fixed-Duration Bispecific Antibody for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
June 15th, 2023
On June 15, 2023, the FDA 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.
News in brief
- Columvi is the first FDA-approved fixed duration CD20xCD3 T-cell engaging bispecific antibody to treat people with relapsed or refractory diffuse large B-cell lymphoma.
- This approval is based on positive results from a Phase I/II study demonstrating durable responses in heavily pretreated and highly refractory patients treated with fixed-duration Columvi.
- Columvi is part of Genentech’s industry-leading portfolio of T-cell engaging bispecifics in non-Hodgkin’s lymphoma.
- DLBCL is an aggressive, hard-to-treat disease and is the most common form of non-Hodgkin lymphoma in the United States.
Supporting Information
“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.”