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FDA Approves a CAR T-cell Therapy to Treat Adults with a Form of Acute Leukemia

The Leukemia & Lymphoma Society (LLS) was an early champion and funder of CAR T-cell therapy 

Rye Brook, N.Y., December 6, 2024 – The U.S. Food and Drug Administration (FDA) has approved obecabtagene autoleucel (Aucatzyl also known as obe-cel), for the treatment of relapsed/refractory acute lymphocytic leukemia (ALL).  

LLS was an early champion and funder of CAR T-cell immunotherapy, which uses genetic engineering to turn a patient’s own T-cells into a personalized army of cancer fighters. Obe-cel targets a protein called CD19, which resides on the surface of ALL cells.  

“With CAR T, we have harnessed the incredible potential of the human immune system to treat blood cancer, offering hope and even potential cures for some patients whose cancer would otherwise be fatal,” says Lee Greenberger, Ph.D., LLS Chief Scientific Officer.  

LLS is funding the next generation of immune-based therapies 

With the approval of obe-cel, there are now seven CAR-T products available in the United States to treat multiple myeloma, leukemia and lymphoma. Greenberger points out that while obe-cel and other CAR T-cell therapies provide significant benefits, they don’t work for everyone.  

LLS has millions of dollars currently invested in research to understand why some patients get limited or even no benefit from CAR T-cell immunotherapy while others achieve long-term remissions and even cures. 

LLS-funded scientists are also researching next generation immunotherapy approaches that train other parts of the immune system, like natural killer cells and macrophages, to make the treatment longer lasting and useful in even more types of blood cancer.  

One-time CAR T-cell infusions can lead to long-term effectiveness  

Typically, CAR T-cell immunotherapy is given as a one-time infusion. In some cases, the treatment leads to long-term remissions and even cures. It will take time to understand the long-term effectiveness of obe-cel. 

Patients in the FELIX clinical trial, which was the basis for the FDA approval, had only short-term remissions after two or more previous treatments or they had never achieved remission at all. In this hard-to-treat population, 42% achieved complete remission within 3 months of treatment with obe-cel. The median duration of complete remission was 14.1 months. As with other CD19 CAR T therapies that are FDA-approved, obe-cel can produce immune and neurological side-effects that must be carefully monitored. 

If you or a loved one need personalized disease, treatment or support information, you can contact one of our Information Specialists: https://www.lls.org/support-resources/information-specialists