FDA Approves Columvi (glofitamab-gxbm) Bispecific Antibody for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Genentech, a member of the Roche Group, announced today 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.
Columvi will be available in the United States in the coming weeks.
DLBCL is an aggressive, hard-to-treat disease and is the most common form of non-Hodgkin’s lymphoma in the United States. While many people with DLBCL are responsive to treatment, the majority of those who relapse or are refractory to subsequent treatments have poor outcomes.
The most common side effects of COLUMVI include: CRS, muscle and bone pain, rash, and tiredness. It is not known if Columvi is safe and effective in children.
The conditional approval of Columvi is based on response rate and durability of response. There are ongoing studies to establish how well the drug works.
