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FDA Approves Immunotherapy for Earlier Use in B-cell Acute Lymphoblastic Leukemia

Blinatumomab will now be available for adults and kids with newly diagnosed B-ALL 

Rye Brook, N.Y., June 18, 2024 – The U.S. Food and Drug Administration on Friday approved blinatumomab (Blincyto®) for earlier treatment of adults and children with CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL).  

“The new approval of blinatumomab expands its use for people with B-ALL. With the new approval, both children and adults who have completed the initial phase of treatment (called induction therapy) can now get blinatumomab along with chemotherapy in the next phase of therapy, called consolidation, which could lead to deeper and more durable responses for more patients” says LLS Chief Scientific Officer Lee Greenberger, Ph.D. 

Researchers followed the study participants for almost five years and observed that approximately 80% of patients who received blinatumomab plus chemotherapy were still alive versus approximately 63% of those treated with chemotherapy alone.  

Blinatumomab is a type of immunotherapy that works by zeroing in on and engaging with two targets—cancer cells and the immune T-cells that can kill them. 

4 Things You Need to Know About the Immune System and Blood Cancer

LLS has championed research into many different approaches that harness the immune system to treat cancer. While immunotherapies like this bispecific T-cell engager (so called “BiTE” therapy), CAR T-cell immunotherapy, checkpoint inhibitors, and antibody drug conjugates have revolutionized blood cancer treatment, LLS continues to look ahead for ways to improve outcomes even more.  

For example, LLS is already investing in research to figure out why B-ALL becomes resistant to treatment in some patients. This is just one of many ways LLS is working to make immunotherapies more effective for more patients and for longer periods of time. LLS is also investing in making next generation immunotherapies even safer and quicker to use. 

LLS President and CEO E. Anders Kolb, M.D., commented on this important new treatment option: “The risk of B-ALL recurrence after the initial phase of treatment is relatively high, making this approval for patients noteworthy. B-ALL is the most common type of ALL and having another effective option available earlier in a patient’s treatment journey is critical for clinicians who are working to give patients more time with their loved ones.” 

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