LINK
OVERVIEW:
A new kind of cancer treatment that uses genetically engineered cells from a patient's immune system to attack their cancer easily cleared a crucial hurdle Wednesday.
The treatment takes cells from a patient's body, modifies the genes, and then reinfuses those modified cells back into the person who has cancer. If the agency approves, it would mark the first time the FDA has approved anything considered to be a "gene therapy product."
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,
For years, scientists have tried to use drugs that stimulate the immune system to fight cancer, and have had only modest success.
In recent years, however, scientists developed a new generation of "immunotherapy"drugs that have produced impressive results for a wide range of cancers by unleashing the body's natural defense system.
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.
RESULTS:
CTL019 produced remissions in 83% of patients, the company told the committee.
UH-OH:
The treatment can produce a life-threatening adverse reaction known as a "cytokine release syndrome," in which the immune system attacks vital organs. In the past, a handful of patients who were getting similar treatments developed by other companies died from serious brain swelling.
Although those sorts of complications did occur in some patients receiving CTL019, the patients recovered and there were no fatalities, the company says.
There are also concerns about possible long-term complications. Scientists use a virus to make the genetic changes in the T cells, raising fears about possible long-term side effects.
QUESTIONS:
OVERVIEW:
A new kind of cancer treatment that uses genetically engineered cells from a patient's immune system to attack their cancer easily cleared a crucial hurdle Wednesday.
The treatment takes cells from a patient's body, modifies the genes, and then reinfuses those modified cells back into the person who has cancer. If the agency approves, it would mark the first time the FDA has approved anything considered to be a "gene therapy product."
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,
For years, scientists have tried to use drugs that stimulate the immune system to fight cancer, and have had only modest success.
In recent years, however, scientists developed a new generation of "immunotherapy"drugs that have produced impressive results for a wide range of cancers by unleashing the body's natural defense system.
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.
RESULTS:
CTL019 produced remissions in 83% of patients, the company told the committee.
UH-OH:
The treatment can produce a life-threatening adverse reaction known as a "cytokine release syndrome," in which the immune system attacks vital organs. In the past, a handful of patients who were getting similar treatments developed by other companies died from serious brain swelling.
Although those sorts of complications did occur in some patients receiving CTL019, the patients recovered and there were no fatalities, the company says.
There are also concerns about possible long-term complications. Scientists use a virus to make the genetic changes in the T cells, raising fears about possible long-term side effects.
QUESTIONS:
- In patients who have pre-existing cytokine problems (CFS, etc), could this be life threatening?
- In patients w AI genes & active AI illnesses, could this stimulate AI disease, or make it worse?
- In patients who can't clear viruses to begin with, could this kill cancer, but return CFS patients to a worse baseline? (If so, just let me die of cancer)