FDA reviewing new T-cell therapy to treat leukemia
A new therapy that generates unique treatment for leukemia in children based on their DNA is undergoing a fast-track review process by the U.S. Food and Drug Administration (FDA).
Manufactured by Novartis, the new therapy harnesses a patient’s T-cells to battle the malignancy. Known as CTL019, the therapy is being investigated to treat B-cell acute lymphoblastic leukemia, according to a press release from Novartis.
“The past five years have seen tremendous progress in the development and application of cellular engineering in an effort to personalize the treatment of cancer," Dr. Carl June, the lead researcher at the Center for Cellular Immunotherapies at University of Pennsylvania’s Perelman School of Medicine, where the therapy was invented, said in the press release. "We now know that it is possible to treat patients in clinical trials across the world using this approach, and the results we have observed mark a potential new paradigm in the treatment of blood cancers that have not responded to standard therapies."
The FDA granted accelerated review to CTL019 after promising results from a Phase II clinical trial, showing more than three-fourths of patients treated with the therapy achieved remission, according to the release.
Organizations in this story
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U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD 20903