Very first cancer ‘living drug’ gets go-ahead
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The US has approved the very first treatment to redesign a patient’s own immune system so it attacks cancer.
The regulator – the US Food and Drug Administration – said its decision was a “historic” moment and medicine was now “injecting a fresh frontier”.
The company Novartis is charging $475,000 (£367,000) for the “living drug” therapy, which leaves 83% of people free of a type of blood cancer.
Doctors in the UK said the announcement was an arousing step forward.
The living drug is tailor-made to each patient, unlike conventional therapies such as surgery or chemotherapy.
It is called CAR-T and is made by extracting white blood cells from the patient’s blood.
The cells are then genetically reprogrammed to seek out and kill cancer.
The cancer-killers are then put back inwards the patient and once they find their target they multiply.
‘Enormously titillating’
Dr Scott Gottlieb, from the FDA, said: “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.
“Fresh technologies such as gene and cell therapies hold out the potential to convert medicine and create an inflection point in our capability to treat and even cure many intractable illnesses.”
The therapy, which will be marketed as Kymriah, works against acute lymphoblastic leukaemia.
Most patients react to normal therapy and Kymriah has been approved for when those treatments fail.
Dr Stephan Grupp, who treated the very first child with CAR-T at the Children’s Hospital of Philadelphia, said the fresh treatment was “enormously arousing”.
“We’ve never seen anything like this before,” he added.
That very first patient had been near to death, but has now been cancer-free for more than five years.
Out of sixty three patients treated with CAR-T therapy, 83% were in accomplish remission within three months and long-term data is still being collected.
However, the therapy is not without risks.
It can cause potentially life-threatening cytokine release syndrome from the rapid proliferation of the CAR-T cells in the bod. This can be managed with drugs.
Fresh era
But the potential of CAR-T technology goes beyond one type of cancer.
Dr David Maloney, medical director of cellular immunotherapy at the Fred Hutchinson Cancer Research Center, said the FDA’s decision was a “milestone”.
He added: “We believe this is just the very first of what will soon be many fresh immunotherapy-based treatments for a diversity of cancers.
CAR-T technology has shown most promise against different blood-based cancers.
However, it has struggled against “solid tumours” such as lung cancer or melanoma.
Dr Prakash Satwani, a paediatric oncologist at Columbia University Medical, said: “The results haven’t been that good when you compare it with acute lymphoblastic leukaemia, but I’m sure the technology will get better in the near future.”
Boosting the immune system is already a cornerstone of modern cancer treatment.
A range of drugs that “take the brakes off” the immune system to permit it to attack cancer more loosely have already been adopted around the world.
CAR-T technology, which goes a step further and redesigns the immune system, is at a much earlier stage.
Prof Peter Johnson, the chief clinician at the charity Cancer Research UK, said: “The very first genetically modified cell therapy to be approved by the FDA is an titillating step forward.
“We still have a lot to learn about how to use it securely and who might benefit from it, so it is significant to recognise this is just a very first step.”
Very first cancer living drug gets go-ahead – Big black cock News
Very first cancer ‘living drug’ gets go-ahead
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The US has approved the very first treatment to redesign a patient’s own immune system so it attacks cancer.
The regulator – the US Food and Drug Administration – said its decision was a “historic” moment and medicine was now “injecting a fresh frontier”.
The company Novartis is charging $475,000 (£367,000) for the “living drug” therapy, which leaves 83% of people free of a type of blood cancer.
Doctors in the UK said the announcement was an arousing step forward.
The living drug is tailor-made to each patient, unlike conventional therapies such as surgery or chemotherapy.
It is called CAR-T and is made by extracting white blood cells from the patient’s blood.
The cells are then genetically reprogrammed to seek out and kill cancer.
The cancer-killers are then put back inwards the patient and once they find their target they multiply.
‘Enormously arousing’
Dr Scott Gottlieb, from the FDA, said: “We’re injecting a fresh frontier in medical innovation with the capability to reprogram a patient’s own cells to attack a deadly cancer.
“Fresh technologies such as gene and cell therapies hold out the potential to convert medicine and create an inflection point in our capability to treat and even cure many intractable illnesses.”
The therapy, which will be marketed as Kymriah, works against acute lymphoblastic leukaemia.
Most patients react to normal therapy and Kymriah has been approved for when those treatments fail.
Dr Stephan Grupp, who treated the very first child with CAR-T at the Children’s Hospital of Philadelphia, said the fresh treatment was “enormously arousing”.
“We’ve never seen anything like this before,” he added.
That very first patient had been near to death, but has now been cancer-free for more than five years.
Out of sixty three patients treated with CAR-T therapy, 83% were in finish remission within three months and long-term data is still being collected.
However, the therapy is not without risks.
It can cause potentially life-threatening cytokine release syndrome from the rapid proliferation of the CAR-T cells in the bod. This can be managed with drugs.
Fresh era
But the potential of CAR-T technology goes beyond one type of cancer.
Dr David Maloney, medical director of cellular immunotherapy at the Fred Hutchinson Cancer Research Center, said the FDA’s decision was a “milestone”.
He added: “We believe this is just the very first of what will soon be many fresh immunotherapy-based treatments for a multiplicity of cancers.
CAR-T technology has shown most promise against different blood-based cancers.
However, it has struggled against “solid tumours” such as lung cancer or melanoma.
Dr Prakash Satwani, a paediatric oncologist at Columbia University Medical, said: “The results haven’t been that superb when you compare it with acute lymphoblastic leukaemia, but I’m sure the technology will get better in the near future.”
Boosting the immune system is already a cornerstone of modern cancer treatment.
A range of drugs that “take the brakes off” the immune system to permit it to attack cancer more loosely have already been adopted around the world.
CAR-T technology, which goes a step further and redesigns the immune system, is at a much earlier stage.
Prof Peter Johnson, the chief clinician at the charity Cancer Research UK, said: “The very first genetically modified cell therapy to be approved by the FDA is an arousing step forward.
“We still have a lot to learn about how to use it securely and who might benefit from it, so it is significant to recognise this is just a very first step.”