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FDA approves very first gene therapy in U.S. to treat leukemia
Last Updated Aug 31, two thousand seventeen 9:11 AM EDT
WASHINGTON — Opening a fresh era in cancer care, the Food and Drug Administration on Wednesday approved the very first treatment that genetically engineers patients’ own blood cells into an army of assassins to seek and ruin childhood leukemia .
The CAR-T cell treatment developed by Novartis and the University of Pennsylvania is the very first type of gene therapy to hit the U.S. market – and one in a powerful but expensive wave of custom-made “living drugs” being tested against blood cancers and some other tumors, too.
FDA called the approval historic.
“This is a brand fresh way of treating cancer,” said Dr. Stephan Grupp of Children’s Hospital of Philadelphia, who treated the very first child with CAR-T cell therapy – a damsel who’d been near death but now is cancer-free for five years and counting. “That’s enormously arousing.”
CAR-T treatment uses gene therapy technics not to fix disease-causing genes but to turbocharge T cells, immune system soldiers that cancer too often can evade. Researchers filter those cells from a patient’s blood, reprogram them to harbor a “chimeric antigen receptor” that zeroes in on cancer, and grow hundreds of millions of copies. Returned to the patient, the revved-up cells can proceed multiplying to fight disease for months or years.
“Just the fact that I get a future is totally remarkable – I shouldn’t be alive right now,” Mitchell Carbon, Nineteen, told CBS News’ Jim Axelrod. After just one infusion, he is now cancer-free.
FDA approves breakthrough CAR-T therapy for leukemia
“It’s a pretty amazing fresh treatment,” Dr. David Agus, director of the USC Norris Westside Cancer Center and CBS News medical contributor, told “CBS This Morning” in July, when an FDA panel voted to recommend approval. “They take the white [blood] cells out of a child with cancer, they send them to [a lab in] Fresh Jersey, and they put in a gene to reprogram these cells to attack the cancer.”
Novartis didn’t instantly disclose the therapy’s price but it is expected to cost hundreds of thousands of dollars. The health news site STAT reported a course of treatment will cost $475,000. It’s made from scrape for every patient.
“We’re injecting a fresh frontier in medical innovation with the capability to reprogram a patient’s own cells to attack a deadly cancer,” said FDA Commissioner Scott Gottlieb.
This very first use of CAR-T therapy is aimed at patients despairingly ill with a common pediatric cancer – acute lymphoblastic leukemia – that strikes more than Three,000 children and youthful adults in the U.S. each year. While most sustain, about fifteen percent relapse despite today’s best treatments, and their prognosis is bleak.
In a key investigate of sixty three advanced patients, eighty three percent went into remission. It’s not clear how long that benefit lasts: Some patients did relapse months later. The others still are being tracked to see how they fare long-term.
© two thousand seventeen CBS Interactive Inc. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed. The Associated Press contributed to this report.
FDA approves CAR-T cancer treatment – very first gene therapy in U
FDA approves very first gene therapy in U.S. to treat leukemia
Last Updated Aug 31, two thousand seventeen 9:11 AM EDT
WASHINGTON — Opening a fresh era in cancer care, the Food and Drug Administration on Wednesday approved the very first treatment that genetically engineers patients’ own blood cells into an army of assassins to seek and demolish childhood leukemia .
The CAR-T cell treatment developed by Novartis and the University of Pennsylvania is the very first type of gene therapy to hit the U.S. market – and one in a powerful but expensive wave of custom-made “living drugs” being tested against blood cancers and some other tumors, too.
FDA called the approval historic.
“This is a brand fresh way of treating cancer,” said Dr. Stephan Grupp of Children’s Hospital of Philadelphia, who treated the very first child with CAR-T cell therapy – a female who’d been near death but now is cancer-free for five years and counting. “That’s enormously arousing.”
CAR-T treatment uses gene therapy technics not to fix disease-causing genes but to turbocharge T cells, immune system soldiers that cancer too often can evade. Researchers filter those cells from a patient’s blood, reprogram them to harbor a “chimeric antigen receptor” that zeroes in on cancer, and grow hundreds of millions of copies. Returned to the patient, the revved-up cells can proceed multiplying to fight disease for months or years.
“Just the fact that I get a future is entirely remarkable – I shouldn’t be alive right now,” Mitchell Carbon, Nineteen, told CBS News’ Jim Axelrod. After just one infusion, he is now cancer-free.
FDA approves breakthrough CAR-T therapy for leukemia
“It’s a pretty amazing fresh treatment,” Dr. David Agus, director of the USC Norris Westside Cancer Center and CBS News medical contributor, told “CBS This Morning” in July, when an FDA panel voted to recommend approval. “They take the white [blood] cells out of a child with cancer, they send them to [a lab in] Fresh Jersey, and they put in a gene to reprogram these cells to attack the cancer.”
Novartis didn’t instantaneously disclose the therapy’s price but it is expected to cost hundreds of thousands of dollars. The health news site STAT reported a course of treatment will cost $475,000. It’s made from scrape for every patient.
“We’re injecting a fresh frontier in medical innovation with the capability to reprogram a patient’s own cells to attack a deadly cancer,” said FDA Commissioner Scott Gottlieb.
This very first use of CAR-T therapy is aimed at patients despairingly ill with a common pediatric cancer – acute lymphoblastic leukemia – that strikes more than Trio,000 children and youthfull adults in the U.S. each year. While most sustain, about fifteen percent relapse despite today’s best treatments, and their prognosis is bleak.
In a key explore of sixty three advanced patients, eighty three percent went into remission. It’s not clear how long that benefit lasts: Some patients did relapse months later. The others still are being tracked to see how they fare long-term.
© two thousand seventeen CBS Interactive Inc. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed. The Associated Press contributed to this report.
FDA approves CAR-T cancer treatment – very first gene therapy in U
FDA approves very first gene therapy in U.S. to treat leukemia
Last Updated Aug 31, two thousand seventeen 9:11 AM EDT
WASHINGTON — Opening a fresh era in cancer care, the Food and Drug Administration on Wednesday approved the very first treatment that genetically engineers patients’ own blood cells into an army of assassins to seek and demolish childhood leukemia .
The CAR-T cell treatment developed by Novartis and the University of Pennsylvania is the very first type of gene therapy to hit the U.S. market – and one in a powerful but expensive wave of custom-made “living drugs” being tested against blood cancers and some other tumors, too.
FDA called the approval historic.
“This is a brand fresh way of treating cancer,” said Dr. Stephan Grupp of Children’s Hospital of Philadelphia, who treated the very first child with CAR-T cell therapy – a doll who’d been near death but now is cancer-free for five years and counting. “That’s enormously titillating.”
CAR-T treatment uses gene therapy mechanisms not to fix disease-causing genes but to turbocharge T cells, immune system soldiers that cancer too often can evade. Researchers filter those cells from a patient’s blood, reprogram them to harbor a “chimeric antigen receptor” that zeroes in on cancer, and grow hundreds of millions of copies. Returned to the patient, the revved-up cells can proceed multiplying to fight disease for months or years.
“Just the fact that I get a future is entirely remarkable – I shouldn’t be alive right now,” Mitchell Carbon, Nineteen, told CBS News’ Jim Axelrod. After just one infusion, he is now cancer-free.
FDA approves breakthrough CAR-T therapy for leukemia
“It’s a pretty amazing fresh treatment,” Dr. David Agus, director of the USC Norris Westside Cancer Center and CBS News medical contributor, told “CBS This Morning” in July, when an FDA panel voted to recommend approval. “They take the white [blood] cells out of a child with cancer, they send them to [a lab in] Fresh Jersey, and they put in a gene to reprogram these cells to attack the cancer.”
Novartis didn’t instantly disclose the therapy’s price but it is expected to cost hundreds of thousands of dollars. The health news site STAT reported a course of treatment will cost $475,000. It’s made from scrape for every patient.
“We’re coming in a fresh frontier in medical innovation with the capability to reprogram a patient’s own cells to attack a deadly cancer,” said FDA Commissioner Scott Gottlieb.
This very first use of CAR-T therapy is aimed at patients despairingly ill with a common pediatric cancer – acute lymphoblastic leukemia – that strikes more than Trio,000 children and youthful adults in the U.S. each year. While most get through, about fifteen percent relapse despite today’s best treatments, and their prognosis is bleak.
In a key examine of sixty three advanced patients, eighty three percent went into remission. It’s not clear how long that benefit lasts: Some patients did relapse months later. The others still are being tracked to see how they fare long-term.
© two thousand seventeen CBS Interactive Inc. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed. The Associated Press contributed to this report.
