The FDA Approves Columvi For Relapsed/Refractory DLBCL

Diffuse large B-cell lymphoma (DLBCL) represents one-third of all non-Hodgkin's lymphoma cases. With immediate treatment, two-thirds of patients will survive 5 years or longer. Yet, research indicates that 30-40% of DLBCL patients will relapse within the first 2 years, and 10-15% will become refractory, meaning that the patient does not respond to treatment. These statistics reveal the significant need for new and more effective DLBCL therapies.

Newly FDA-Approved Therapy

“On June 15th, 2023, the Food and Drug Administration (FDA) approved Columvi (glofitamab-gxbm) to treat adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or for those with large B-cell lymphoma resulting from follicular lymphoma after two or more lines of therapy.”

How It Works

Columvi is a unique bispecific antibody that is designed to bind to 1 part of an immune cell called a T-cell and 2 parts of an immune cell called a B-cell at the same time. By binding to these cells, Columvi brings the cells close enough for the T-cell to engage with and release proteins called cytokines, which then leads to the death of cancerous B-cells. It may also harm healthy B-cells. 

“Results demonstrated that patients treated with Columvi achieved durable remission, including 56% of patients who achieved an overall response (patients with a partial or complete response to treatment) and 43% obtained a complete response (the disappearance of all signs of cancer) to therapy.”

Possible side effects

1. Cytokine release syndrome (CRS): can cause a fever, chills, irregular heartbeat, and difficulty breathing. Because of the serious nature of CRS, Columvi medication will be administered in a step-dose escalation protocol.
2. Neurological issues: headache, confusion, trouble speaking, dizziness, tremors, fatigue
3. Serious infections
4. Growth in your tumor or tumor-related problems

For a detailed list of side effects, see HERE.

The most common side effects reported in the study included cytokine release syndrome (70%), fatigue (20%), musculoskeletal pain (21%) and rash (20%). Although cytokine release syndrome may be serious or life-threatening, the occurrences of this side effect in the study were generally low-grade, with 52% considered to be mild and 14% considered to be moderate.

“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.”