Columvi FDA Approval History
Last updated by Judith Stewart, BPharm on June 16, 2023.
FDA Approved: Yes (First approved June 15, 2023)
Brand name: Columvi
Generic name: glofitamab-gxbm
Dosage form: Injection
Company: Genentech, Inc.
Treatment for: Diffuse Large B-Cell Lymphoma
Columvi (glofitamab-gxbm) is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) 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.
- Large B-cell lymphoma (LBCL) is an aggressive type of non-Hodgkin’s lymphoma (NHL) resulting from the malignant proliferation of B-cells during their various stages of development. Diffuse large B-cell lymphoma not otherwise specified (DLBCL, NOS) is the most common category of large B-cell lymphoma (LBCL). Follicular lymphoma (FL) is the most common slow-growing form of non-Hodgkin’s lymphoma. FL can transform to more aggressive malignancies, including large B-cell lymphoma (LBCL).
- Columvi contains glofitamab-gxbm which is a CD20xCD3 T-cell engaging bispecific antibody designed with a novel 2:1 structural format. It is designed to target the CD3 protein on the surface of T-cells (a type of immune cell) and the CD20 protein on the surface of B-cells (which are cancerous in DLBCL). This dual-targeting activates and redirects a patient’s existing T-cells to engage and eliminate the target B-cells by releasing cancer cell-killing proteins from the T-cells.
- The FDA accelerated approval of Columvi is based on positive results from the Phase I/II NP30179 study which showed durable responses, with a 56% overall response rate, a 43% complete response (remission) rate, and a median duration of response of 1.5 years.
- Columvi is administered as an intravenous infusion according to a three week treatment cycle. During the first cycle, patients will receive an infusion of obinutuzumab on day 1, then an infusion of Columvi on day 8 and day 15. From the second cycle onwards, patients will receive an infusion of Columvi once every three weeks.
- The Columvi product label carries a Boxed Warning for Cytokine Release Syndrome (CRS) which can be fatal. Columvi infusions must be administered in a facility equipped to monitor and manage CRS and patients should receive the first infusion (and any recommended subsequent infusions) in hospital. Columvi is administered according to a "step-up dosing schedule" with premedications (acetaminophen, antihistamine and a corticosteroid) to reduce the risk of CRS.
- Warnings and precautions associated with Columvi include neurologic toxicity, serious or fatal infections, serious tumor flare reactions, and embryo-fetal toxicity.
- Common systemic adverse reactions include cytokine release syndrome, musculoskeletal pain, rash, and fatigue.
Common laboratory abnormalities include decreased lymphocyte count, decreased phosphate levels, decreased neutrophil count, increased uric acid levels, and decreased fibrinogen.
Development timeline for Columvi
Further information
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