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Latest FDA Approval Joins a Torrent of New Treatments for Aggressive Lymphoma Subtype

Rye Brook, N.Y., July 10, 2023 – The U.S. Food and Drug Administration (FDA) recently approved glofitamab-gxbm (Columvi™) to treat adults with diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma arising from follicular lymphoma, whose disease has not responded or relapsed after two prior therapies.

“Glofitamab is the third drug approved this year alone to treat DLBCL, the most common form of lymphoma,” said LLS’s Chief Scientific Officer Lee Greenberger, Ph.D. “It’s extraordinary to see this many approvals for a specific disease in such a short period. These approvals, all immunotherapies, are a testament to the strength of using a person’s immune system to treat their blood cancer, something The Leukemia & Lymphoma Society has continually supported since the 1990s.”

Glofitamab is a bispecific antibody, meaning that it has two different targets — one piece of the antibody binds to the CD3 protein on immune T cells. The second half of the antibody binds to CD20 protein on the surface of cancer cells. This dual targeting helps the immune system zero in on and kill the cancer cells. 

Forty-three percent of the 132 patients in the clinical trial derived a complete response, meaning there were no detectable signs of cancer at follow-up. Of these patients, 68.5% retained a response for at least nine months. 

Seventy percent of patients in the trial developed so-called cytokine release syndrome (CRS) of low grade. CRS can develop as a side effect of immunotherapy, and it occurs when immune cells become over-activated. If this occurs, people may experience increased inflammation throughout the body which may interfere with body functions. 

CRS is common with immunotherapies of this type and typically resolves with no treatment or with the use of other therapeutics. Some patients in the trial, however, experienced some form of mild neurotoxic events such as headache and memory loss. 

Glofitamab is approved as a fixed-duration treatment, meaning patients receive the drug for 12 cycles which should be completed in 8.5 months. In contrast, other therapies are often administered continuously until a patient’s disease worsens or stops responding to treatment.

“A fixed-duration immunotherapy is attractive to patients because it could provide patients with a less toxic treatment option,” said Dr. Greenberger. “LLS has made maximizing the effectiveness of therapies while limiting exposure to treatments that could lead to severe side effects one of its many research priorities. In fact, LLS has invested more than $10 million over the past year to explore next generation immunotherapies.”
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