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A U.S. Food and Drug Administration advisory panel endorsed a fresh breakthrough therapy for advanced leukemia on Wednesday called CTL019 –- a first-of-its-kind cancer treatment, in an emerging category known as CAR-T immunotherapy.
The treatment is the result of a joint effort inbetween the University of Pennsylvania and pharmaceutical giant Novartis. In 2015, the two launched a examine called ELIANA to investigate the use of CTL019 in children with a difficult-to-treat leukemia. The preliminary results of the examine, released last month, helped sway the experienced panel, who voted 10-0 to urge the FDA to recommend the drug for children and youthfull adults with the devastating disease, pending approval.
The FDA is expected to make a final decision on approval by October Trio. If approved, CTL019 will become the very first treatment of its kind on the market. Below are some of the most significant questions about this novel therapy.
How does CAR-T therapy work?
Chimeric Antigen Receptor T-cell (CAR-T) therapy leverages patients’ own immune system cells to fight tumors. Doctors extract a specialized type of white blood cells, known as T-cells, from the patient and re-engineer them to home in on and attack cancerous cells. When the modified cells are returned to the patient, they seek out and ruin the cancer.
Immunotherapy is a growing field in cancer treatment and medications that alter the body’s immune system to fight cancer are already on the market. But, CTL019 is the very first that is custom-tailored for each individual patient, requiring a sophisticated procedure that involves removing and substituting a patients’ own cells.
Who can CTL019 help?
The committee’s approval for CAR-T therapy applies to children and youthfull adults, ages three to 25, with a form of leukemia called relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). ALL is the most common type of cancer in children, with clinicians diagnosing about Three,000 cases in Americans below the age of twenty each year.
Traditional chemotherapy can help many children with cancer, but for those with relapsed or refractory disease, treatment options are limited and 5-year survival rates are often below thirty percent.
How well does it work?
In preliminary results of the landmark ELIANA trial, which studied fifty children with ALL over six months, researchers reported that eighty two percent of patients treated with CTL019 achieved accomplish remission –- meaning an eradication of cancer cells –- after three months. Overall survival was eighty nine percent after six months and seventy nine percent after twelve months. The researchers plan to go after each patient for fifteen years and will release information on 5-year survival rates when it becomes available.
What are the side effects?
Adverse events related to this therapy are a major concern. In the aforementioned trial, almost eight out of ten patients developed cytokine release syndrome, a total-body inflammatory response that mimics infection. Many of these patients required treatment in the intensive care unit (ICU), but all of them survived. Other adverse events included true infections, hallucinations and low blood cell counts. Despite the side effects, the accomplished committee still felt that the benefits of the therapy outweighed the risks.
Could this drug be used for other cancers?
A handful of other pharmaceutical companies are looking closely at CAR-T as a treatment option for other blood cancers, including a class of cancers known as lymphomas. Some researchers are also investigating CAR-T as a hopeful treatment for treating patients with devastating solid tumors like the brain cancer glioblastoma and a form of lung cancer known as mesothelioma. Results from many of these preliminary trials are expected in the next year.
About CAR-T leukemia therapy, part of a fresh wave in cancer treatment – ABC News
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- Yahoo!-ABC News Network | © two thousand seventeen ABC News Internet Ventures. All rights reserved.
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Science Photo Library /Getty Pictures
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A U.S. Food and Drug Administration advisory panel endorsed a fresh breakthrough therapy for advanced leukemia on Wednesday called CTL019 –- a first-of-its-kind cancer treatment, in an emerging category known as CAR-T immunotherapy.
The treatment is the result of a joint effort inbetween the University of Pennsylvania and pharmaceutical giant Novartis. In 2015, the two launched a probe called ELIANA to investigate the use of CTL019 in children with a difficult-to-treat leukemia. The preliminary results of the examine, released last month, helped sway the accomplished panel, who voted 10-0 to urge the FDA to recommend the drug for children and youthful adults with the devastating disease, pending approval.
The FDA is expected to make a final decision on approval by October Trio. If approved, CTL019 will become the very first treatment of its kind on the market. Below are some of the most significant questions about this novel therapy.
How does CAR-T therapy work?
Chimeric Antigen Receptor T-cell (CAR-T) therapy leverages patients’ own immune system cells to fight tumors. Doctors extract a specialized type of white blood cells, known as T-cells, from the patient and re-engineer them to home in on and attack cancerous cells. When the modified cells are returned to the patient, they seek out and ruin the cancer.
Immunotherapy is a growing field in cancer treatment and medications that alter the body’s immune system to fight cancer are already on the market. But, CTL019 is the very first that is custom-tailored for each individual patient, requiring a complicated procedure that involves removing and substituting a patients’ own cells.
Who can CTL019 help?
The committee’s approval for CAR-T therapy applies to children and youthful adults, ages three to 25, with a form of leukemia called relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). ALL is the most common type of cancer in children, with clinicians diagnosing about Trio,000 cases in Americans below the age of twenty each year.
Traditional chemotherapy can help many children with cancer, but for those with relapsed or refractory disease, treatment options are limited and 5-year survival rates are often below thirty percent.
How well does it work?
In preliminary results of the landmark ELIANA trial, which studied fifty children with ALL over six months, researchers reported that eighty two percent of patients treated with CTL019 achieved finish remission –- meaning an eradication of cancer cells –- after three months. Overall survival was eighty nine percent after six months and seventy nine percent after twelve months. The researchers plan to go after each patient for fifteen years and will release information on 5-year survival rates when it becomes available.
What are the side effects?
Adverse events related to this therapy are a major concern. In the aforementioned trial, almost eight out of ten patients developed cytokine release syndrome, a total-body inflammatory response that mimics infection. Many of these patients required treatment in the intensive care unit (ICU), but all of them survived. Other adverse events included true infections, hallucinations and low blood cell counts. Despite the side effects, the experienced committee still felt that the benefits of the therapy outweighed the risks.
Could this drug be used for other cancers?
A handful of other pharmaceutical companies are looking closely at CAR-T as a treatment option for other blood cancers, including a class of cancers known as lymphomas. Some researchers are also investigating CAR-T as a hopeful treatment for treating patients with devastating solid tumors like the brain cancer glioblastoma and a form of lung cancer known as mesothelioma. Results from many of these preliminary trials are expected in the next year.
About CAR-T leukemia therapy, part of a fresh wave in cancer treatment – ABC News
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Yahoo!-ABC News Network | © two thousand seventeen ABC News Internet Ventures. All rights reserved.
- Yahoo!-ABC News Network | © two thousand seventeen ABC News Internet Ventures. All rights reserved.
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Science Photo Library /Getty Pics
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A U.S. Food and Drug Administration advisory panel endorsed a fresh breakthrough therapy for advanced leukemia on Wednesday called CTL019 –- a first-of-its-kind cancer treatment, in an emerging category known as CAR-T immunotherapy.
The treatment is the result of a joint effort inbetween the University of Pennsylvania and pharmaceutical giant Novartis. In 2015, the two launched a examine called ELIANA to investigate the use of CTL019 in children with a difficult-to-treat leukemia. The preliminary results of the probe, released last month, helped sway the accomplished panel, who voted 10-0 to urge the FDA to recommend the drug for children and youthfull adults with the devastating disease, pending approval.
The FDA is expected to make a final decision on approval by October Trio. If approved, CTL019 will become the very first treatment of its kind on the market. Below are some of the most significant questions about this novel therapy.
How does CAR-T therapy work?
Chimeric Antigen Receptor T-cell (CAR-T) therapy leverages patients’ own immune system cells to fight tumors. Doctors extract a specialized type of white blood cells, known as T-cells, from the patient and re-engineer them to home in on and attack cancerous cells. When the modified cells are returned to the patient, they seek out and ruin the cancer.
Immunotherapy is a growing field in cancer treatment and medications that alter the body’s immune system to fight cancer are already on the market. But, CTL019 is the very first that is custom-tailored for each individual patient, requiring a complicated procedure that involves removing and substituting a patients’ own cells.
Who can CTL019 help?
The committee’s approval for CAR-T therapy applies to children and youthful adults, ages three to 25, with a form of leukemia called relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). ALL is the most common type of cancer in children, with clinicians diagnosing about Trio,000 cases in Americans below the age of twenty each year.
Traditional chemotherapy can help many children with cancer, but for those with relapsed or refractory disease, treatment options are limited and 5-year survival rates are often below thirty percent.
How well does it work?
In preliminary results of the landmark ELIANA trial, which studied fifty children with ALL over six months, researchers reported that eighty two percent of patients treated with CTL019 achieved finish remission –- meaning an eradication of cancer cells –- after three months. Overall survival was eighty nine percent after six months and seventy nine percent after twelve months. The researchers plan to go after each patient for fifteen years and will release information on 5-year survival rates when it becomes available.
What are the side effects?
Adverse events related to this therapy are a major concern. In the aforementioned trial, almost eight out of ten patients developed cytokine release syndrome, a total-body inflammatory response that mimics infection. Many of these patients required treatment in the intensive care unit (ICU), but all of them survived. Other adverse events included true infections, hallucinations and low blood cell counts. Despite the side effects, the pro committee still felt that the benefits of the therapy outweighed the risks.
Could this drug be used for other cancers?
A handful of other pharmaceutical companies are looking closely at CAR-T as a treatment option for other blood cancers, including a class of cancers known as lymphomas. Some researchers are also investigating CAR-T as a hopeful treatment for treating patients with devastating solid tumors like the brain cancer glioblastoma and a form of lung cancer known as mesothelioma. Results from many of these preliminary trials are expected in the next year.
About CAR-T leukemia therapy, part of a fresh wave in cancer treatment – ABC News
Sections
Yahoo!-ABC News Network | © two thousand seventeen ABC News Internet Ventures. All rights reserved.
- Yahoo!-ABC News Network | © two thousand seventeen ABC News Internet Ventures. All rights reserved.
- 0 Shares
Science Photo Library /Getty Pics
- 0 Shares
A U.S. Food and Drug Administration advisory panel endorsed a fresh breakthrough therapy for advanced leukemia on Wednesday called CTL019 –- a first-of-its-kind cancer treatment, in an emerging category known as CAR-T immunotherapy.
The treatment is the result of a joint effort inbetween the University of Pennsylvania and pharmaceutical giant Novartis. In 2015, the two launched a examine called ELIANA to investigate the use of CTL019 in children with a difficult-to-treat leukemia. The preliminary results of the explore, released last month, helped sway the pro panel, who voted 10-0 to urge the FDA to recommend the drug for children and youthful adults with the devastating disease, pending approval.
The FDA is expected to make a final decision on approval by October Three. If approved, CTL019 will become the very first treatment of its kind on the market. Below are some of the most significant questions about this novel therapy.
How does CAR-T therapy work?
Chimeric Antigen Receptor T-cell (CAR-T) therapy leverages patients’ own immune system cells to fight tumors. Doctors extract a specialized type of white blood cells, known as T-cells, from the patient and re-engineer them to home in on and attack cancerous cells. When the modified cells are returned to the patient, they seek out and ruin the cancer.
Immunotherapy is a growing field in cancer treatment and medications that alter the body’s immune system to fight cancer are already on the market. But, CTL019 is the very first that is custom-tailored for each individual patient, requiring a elaborate procedure that involves removing and substituting a patients’ own cells.
Who can CTL019 help?
The committee’s approval for CAR-T therapy applies to children and youthfull adults, ages three to 25, with a form of leukemia called relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). ALL is the most common type of cancer in children, with clinicians diagnosing about Trio,000 cases in Americans below the age of twenty each year.
Traditional chemotherapy can help many children with cancer, but for those with relapsed or refractory disease, treatment options are limited and 5-year survival rates are often below thirty percent.
How well does it work?
In preliminary results of the landmark ELIANA trial, which studied fifty children with ALL over six months, researchers reported that eighty two percent of patients treated with CTL019 achieved accomplish remission –- meaning an eradication of cancer cells –- after three months. Overall survival was eighty nine percent after six months and seventy nine percent after twelve months. The researchers plan to go after each patient for fifteen years and will release information on 5-year survival rates when it becomes available.
What are the side effects?
Adverse events related to this therapy are a major concern. In the aforementioned trial, almost eight out of ten patients developed cytokine release syndrome, a total-body inflammatory response that mimics infection. Many of these patients required treatment in the intensive care unit (ICU), but all of them survived. Other adverse events included true infections, hallucinations and low blood cell counts. Despite the side effects, the experienced committee still felt that the benefits of the therapy outweighed the risks.
Could this drug be used for other cancers?
A handful of other pharmaceutical companies are looking closely at CAR-T as a treatment option for other blood cancers, including a class of cancers known as lymphomas. Some researchers are also investigating CAR-T as a hopeful treatment for treating patients with devastating solid tumors like the brain cancer glioblastoma and a form of lung cancer known as mesothelioma. Results from many of these preliminary trials are expected in the next year.