An advisory panel on Wednesday unanimously urged the US Food and Drug Administration to approve a cutting-edge cancer therapy that genetically alters a patient’s own immune system to attack leukemia.
The treatment known as CTL019 was developed by lead researcher Carl June at the University of Pennsylvania and licensed to Novartis as a treatment for pediatric acute lymphoblastic leukemia.
It works by taking a patient’s own white blood cells, called T-cells, then altering them to allow them to recognize and kill cancer cells.
The treatment is best known for saving the life of a young girl named Emily Whitehead, who is now 12 and has been cancer-free for the past five years. She attended Wednesday’s hearing with her parents.
In 2014, US regulators designated CTL019 as a “breakthrough therapy” and put the experimental immunotherapy agent on the fast track to market approval, after 89 percent of leukemia patients in early trials saw their cancers disappear.
It was the first cancer immunotherapy to receive the breakthrough designation. More are expected to follow in the coming years as the field of immunotherapy grows.
The approach works by extracting a patient’s T-cells, then genetically programming them in the lab to target cancer cells that produce a protein called CD19.
The altered T-cells are then re-injected into the patient’s body, where they multiply and attack cancer.
The FDA does not have to accept the recommendations of its advisory panel, but usually does.
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