FDA Approves CAR T-cell Therapy for Pediatric Acute Lymphoblastic Leukemia (ALL)
FDA Approves CAR T-cell Therapy for Pediatric Acute Lymphoblastic Leukemia (ALL)
The US Food and Drug Administration (FDA) has approved Kymriah (tisagenlecleucel) for certain children, adolescents, and youthfull adults with a form of acute lymphoblastic leukemia (ALL). It’s the very first gene therapy available in the United States.
Kymriah is a type of CAR T-cell therapy. The therapy is designed to help the body’s own immune system fight cancer. Each dose of the drug is customized to the individual patient. It’s made using a patient’s T-cells, a type of white blood cell that helps fight diseases in the bod. The T-cells are collected from the patient and sent to a lab where they are switched in a way that programs them to find and kill the leukemia cells. They are then given back to the patient through an infusion.
The drug is approved for youthfull people ages three to twenty five years who have B-cell precursor ALL that has not gotten better or has come back after standard treatment.
The FDA based its approval on a puny clinical trial of sixty three youthful people with B-cell precursor ALL who had run out of all other options for treatment. The overall remission rate within three months of treatment was 83%. The FDA’s act goes after a vote in favor of approval by a panel of outside experts.
Kymriah can cause severe side effects
Kymriah comes with a boxed warning for a potentially life-threating syndrome called cytokine release syndrome (CRS), which causes high fever, flu-like symptoms, and potential for serious neurological switches. Other severe side effects include infection, low blood pressure, kidney problems, and decreased oxygen. CRS and other serious side effects usually occur within the very first few weeks after the infusion.
The FDA has also expanded the approval of Actemra (tocilizumab) to treat CRS in children two years of age or older. In addition, it has put some extra safety requirements in place. Treatment with Kymriah will be available only at specially certified hospitals and clinics, and medical staff will get special training to manage CRS and serious neurological switches. Not all patients treated with Kymriah will develop CRS and need Actemra. It is significant for all patients and their caregivers to understand the signs and symptoms of CRS and know what to do if those symptoms happen.
The FDA approved Kymriah using breakthrough therapy and priority review designations, which are ways to speed up the evaluation of drugs to treat serious conditions.
Kymriah is marketed by Novartis Pharmaceuticals Corp. Actemra is marketed by Genentech, Inc.
FDA Approves CAR T-cell Therapy for Pediatric Acute Lymphoblastic Leukemia (ALL)
FDA Approves CAR T-cell Therapy for Pediatric Acute Lymphoblastic Leukemia (ALL)
The US Food and Drug Administration (FDA) has approved Kymriah (tisagenlecleucel) for certain children, adolescents, and youthfull adults with a form of acute lymphoblastic leukemia (ALL). It’s the very first gene therapy available in the United States.
Kymriah is a type of CAR T-cell therapy. The therapy is designed to help the body’s own immune system fight cancer. Each dose of the drug is customized to the individual patient. It’s made using a patient’s T-cells, a type of white blood cell that helps fight diseases in the bod. The T-cells are collected from the patient and sent to a lab where they are switched in a way that programs them to find and kill the leukemia cells. They are then given back to the patient through an infusion.
The drug is approved for youthful people ages three to twenty five years who have B-cell precursor ALL that has not gotten better or has come back after standard treatment.
The FDA based its approval on a puny clinical trial of sixty three youthfull people with B-cell precursor ALL who had run out of all other options for treatment. The overall remission rate within three months of treatment was 83%. The FDA’s act goes after a vote in favor of approval by a panel of outside experts.
Kymriah can cause severe side effects
Kymriah comes with a boxed warning for a potentially life-threating syndrome called cytokine release syndrome (CRS), which causes high fever, flu-like symptoms, and potential for serious neurological switches. Other severe side effects include infection, low blood pressure, kidney problems, and decreased oxygen. CRS and other serious side effects usually occur within the very first few weeks after the infusion.
The FDA has also expanded the approval of Actemra (tocilizumab) to treat CRS in children two years of age or older. In addition, it has put some extra safety requirements in place. Treatment with Kymriah will be available only at specially certified hospitals and clinics, and medical staff will get special training to manage CRS and serious neurological switches. Not all patients treated with Kymriah will develop CRS and need Actemra. It is significant for all patients and their caregivers to understand the signs and symptoms of CRS and know what to do if those symptoms happen.
The FDA approved Kymriah using breakthrough therapy and priority review designations, which are ways to speed up the evaluation of drugs to treat serious conditions.
Kymriah is marketed by Novartis Pharmaceuticals Corp. Actemra is marketed by Genentech, Inc.
FDA Approves CAR T-cell Therapy for Pediatric Acute Lymphoblastic Leukemia (ALL)
FDA Approves CAR T-cell Therapy for Pediatric Acute Lymphoblastic Leukemia (ALL)
The US Food and Drug Administration (FDA) has approved Kymriah (tisagenlecleucel) for certain children, adolescents, and youthful adults with a form of acute lymphoblastic leukemia (ALL). It’s the very first gene therapy available in the United States.
Kymriah is a type of CAR T-cell therapy. The therapy is designed to help the body’s own immune system fight cancer. Each dose of the drug is customized to the individual patient. It’s made using a patient’s T-cells, a type of white blood cell that helps fight diseases in the assets. The T-cells are collected from the patient and sent to a lab where they are switched in a way that programs them to find and kill the leukemia cells. They are then given back to the patient through an infusion.
The drug is approved for youthful people ages three to twenty five years who have B-cell precursor ALL that has not gotten better or has come back after standard treatment.
The FDA based its approval on a petite clinical trial of sixty three youthfull people with B-cell precursor ALL who had run out of all other options for treatment. The overall remission rate within three months of treatment was 83%. The FDA’s act goes after a vote in favor of approval by a panel of outside experts.
Kymriah can cause severe side effects
Kymriah comes with a boxed warning for a potentially life-threating syndrome called cytokine release syndrome (CRS), which causes high fever, flu-like symptoms, and potential for serious neurological switches. Other severe side effects include infection, low blood pressure, kidney problems, and decreased oxygen. CRS and other serious side effects usually occur within the very first few weeks after the infusion.
The FDA has also expanded the approval of Actemra (tocilizumab) to treat CRS in children two years of age or older. In addition, it has put some extra safety requirements in place. Treatment with Kymriah will be available only at specially certified hospitals and clinics, and medical staff will get special training to manage CRS and serious neurological switches. Not all patients treated with Kymriah will develop CRS and need Actemra. It is significant for all patients and their caregivers to understand the signs and symptoms of CRS and know what to do if those symptoms happen.
The FDA approved Kymriah using breakthrough therapy and priority review designations, which are ways to speed up the evaluation of drugs to treat serious conditions.
Kymriah is marketed by Novartis Pharmaceuticals Corp. Actemra is marketed by Genentech, Inc.
FDA Approves CAR T-cell Therapy for Pediatric Acute Lymphoblastic Leukemia (ALL)
FDA Approves CAR T-cell Therapy for Pediatric Acute Lymphoblastic Leukemia (ALL)
The US Food and Drug Administration (FDA) has approved Kymriah (tisagenlecleucel) for certain children, adolescents, and youthful adults with a form of acute lymphoblastic leukemia (ALL). It’s the very first gene therapy available in the United States.
Kymriah is a type of CAR T-cell therapy. The therapy is designed to help the body’s own immune system fight cancer. Each dose of the drug is customized to the individual patient. It’s made using a patient’s T-cells, a type of white blood cell that helps fight diseases in the bod. The T-cells are collected from the patient and sent to a lab where they are switched in a way that programs them to find and kill the leukemia cells. They are then given back to the patient through an infusion.
The drug is approved for youthful people ages three to twenty five years who have B-cell precursor ALL that has not gotten better or has come back after standard treatment.
The FDA based its approval on a petite clinical trial of sixty three youthful people with B-cell precursor ALL who had run out of all other options for treatment. The overall remission rate within three months of treatment was 83%. The FDA’s activity goes after a vote in favor of approval by a panel of outside experts.
Kymriah can cause severe side effects
Kymriah comes with a boxed warning for a potentially life-threating syndrome called cytokine release syndrome (CRS), which causes high fever, flu-like symptoms, and potential for serious neurological switches. Other severe side effects include infection, low blood pressure, kidney problems, and decreased oxygen. CRS and other serious side effects usually occur within the very first few weeks after the infusion.
The FDA has also expanded the approval of Actemra (tocilizumab) to treat CRS in children two years of age or older. In addition, it has put some extra safety requirements in place. Treatment with Kymriah will be available only at specially certified hospitals and clinics, and medical staff will get special training to manage CRS and serious neurological switches. Not all patients treated with Kymriah will develop CRS and need Actemra. It is significant for all patients and their caregivers to understand the signs and symptoms of CRS and know what to do if those symptoms happen.
The FDA approved Kymriah using breakthrough therapy and priority review designations, which are ways to speed up the evaluation of drugs to treat serious conditions.
Kymriah is marketed by Novartis Pharmaceuticals Corp. Actemra is marketed by Genentech, Inc.