On June 15, 2023, Roche’s independent subsidiary and biotechnology company – Genentech, announced that their bispecific antibody Columvi (glofitamab-gxbm) has been given accelerated approval by The US Food and Drugs Administration (FDA).
This accelerated approval is a result of the positive results that Columvi demonstrated in clinical trials in patients with relapsed or refractory (R/R) diffuse large B cell Lymphoma (DLBCL). These patients received fixed-duration administration of Columvi and durable remission was observed in them, with a chance of complete remission.
Explore quality insights into the Global Non-Hodgkin Lymphoma Treatment Market and learn about the emerging trends, market size, major players, and the latest FDA approvals. Find more quality information on this by accessing comprehensive Market Research on the Global Non-Hodgkin Lymphoma Treatment Market.
Columvi is a bispecific CD20xCD3 T-Cell engager that can be administrated as a subcutaneous injection for a fixed duration. It is the first and only approved medicine for R/R DLBCL and other forms of LBCL.
DLBCL is the most common type of non-Hodgkin lymphoma, which is a type of lymphatic cancer. This disease is aggressive and has been a major cause of mortality in adults and treatment for it has been difficult. However, Columvi as a treatment option has the potential to change this.
“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.” - Krish Patel, M.D., Director of the Lymphoma Program at the Swedish Cancer Institute in Seattle and investigator of the Columvi Phase I/II NP30179 study.
Based on the above statement by Krish Patel, there’s a chance that it could provide complete remission in some patients. Additionally, the fixed duration of treatment decreases the risk of side effects and provides patients with time off treatment. This makes Columvi an ideal medicine for treatment of R/R DLBCL.
Columvi received its first approval in March from Canada after Health Canada authorized it for treatment of R/R DLBCL. Now, after the US FDA’s approval, will be made available in the United States in the upcoming weeks. It will be interesting to see how Columvi affects the market Bispecific.
However, one thing is for sure - it will prove to be a great treatment option for patients with R/R DLBCL and other forms of LBCL who often suffer from poor prognosis and mortality.