Novartis CAR-T immunotherapy strongly endorsed by FDA advisory panel
july 2017 by jm
This is very exciting stuff, cytokine release syndrome risks notwithstanding.car-t immunotherapy cancer novartis trials fda drugs t-cells immune-system medicine leukemia ctl019
The new treatment is known as CAR-T cell immunotherapy. It works by removing key immune system cells known as T cells from the patient so scientists can genetically modify them to seek out and attack only cancer cells. That's why some scientists refer to this as a "living drug."
Doctors then infuse millions of the genetically modified T cells back into the patient's body so they can try to obliterate the cancer cells and hopefully leave healthy tissue unscathed.
"It's truly a paradigm shift," said Dr. David Lebwohl, who heads the CAR-T Franchise Global Program at the drug company Novartis, which is seeking the FDA's approval for the treatment. "It represents a new hope for patients."
The drug endorsed by the advisory panel is known as CTL019 or tisagenlecleucel. It was developed to treat children and young adults ages 3 to 25 who have relapsed after undergoing standard treatment for B cell acute lymphoblastic leukemia, which is the most common childhood cancer in the United States.
While this blood cell cancer can be highly curable, some patients fail to respond to standard treatments; and a significant proportion of patients experience relapses that don't respond to follow-up therapies.
"There is a major unmet medical need for treatment options" for these patients, Dr. Stephen Hunger, who helped study at the Children's Hospital of Philadelphia, told the committee.
In the main study that the company submitted as evidence in seeking FDA approval, doctors at 25 sites in 11 countries administered the treatment to 88 patients. The patients, ages 3 to 23, had failed standard treatment or experienced relapses and failed to respond to follow-up standard treatment. CTL019 produced remissions in 83 percent of patients, the company told the committee.
july 2017 by jm
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