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The US Food and Drug Administration (FDA) on Wednesday gave a green light to Novartis AG's leukemia treatment, marking the first time that a highly-anticipated new type of potent gene-modifying immunotherapy has gained approval in the US.
The treatment, to be sold under the name Kymriah, was approved for patients up to 25-years-old who have relapsed or were not helped by initial treatment for B-cell acute lymphoblastic leukemia.
Kymriah belongs to a new class of drugs called chimeric antigen receptor T-cell, or CAR T-cell, therapy.
The treatment involves removing disease-fighting T-cells from a patient, genetically modifying them to better recognise and fight cancer and then replacing them in the patient, where they can circulate for years seeking out the disease.
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‘New frontier’
“We’re entering a new frontier in medical innovation with the ability to reprogramme a patient’s own cells to attack a deadly cancer,” FDA commissioner Scott Gottlieb said in a statement.
Novartis has not yet announced the cost for the therapy, but British health authorities have said a price of $649,000 (€546,000) for a one-time treatment would be justified given the significant benefits, according to a Kaiser Health News report last week.
Reuters