In a move that the US Food and Drug Administration (FDA) itself called “a historic action,” the agency has approved a treatment made by Swiss drug giant Novartis that uses a virus to genetically alter a patient’s own white blood cells to battle acute lymphoblastic leukemia.
According to Novartis, it would charge $475,000 per patient, but patients who do not respond within a month of treatment will not be charged.
The treatment, called Kymriah, aims to give some patients a second chance after first-line drugs have failed. This may happen in up to a fifth of patients, according to the FDA. Each dose of Kymriah contains a patient’s own immune cells, which are sent to a lab to be genetically modified using a virus. This therapy — known as chimeric antigen receptor T-cell therapy, or CAR-T — gives the cells the ability to recognize and kill the source of the cancer.
“We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” said FDA Commissioner Scott Gottlieb in a statement.
“We’ve never seen anything like this before and I believe this therapy may become the new standard of care for this patient population,” said Dr. Stephan Grupp, director of cancer immunotherapy at Children’s Hospital of Philadelphia, which spearheaded this research.
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