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The Engineer
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Engineering Immune Cells to Fight Cancer - FDA Approved!

09/06/2017 9:52 AM

I came across this article and figured I'd pass it along. Pretty amazing results! Price tag is a bit steep though...

FDA Approves Groundbreaking Gene Therapy for Cancer

A revolutionary cancer therapy that uses genetically engineered immune cells has been approved by the U.S. Food and Drug Administration, ushering in a new era of cancer treatment. The FDA calls the treatment, made by Novartis, the “first gene therapy” in the U.S. The therapy is designed to treat an often-lethal type of blood and bone marrow cancer that affects children and young adults. Known as a CAR-T therapy, the approach has shown remarkable results in patients. The one-time treatment will cost $475,000, but Novartis says there will be no charge if a patient doesn't respond to the therapy within a month.

“We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” said FDA commissioner Scott Gottlieb in a statement. The therapy, which will be marketed as Kymriah, is a customized treatment that uses a patient’s own T cells, a type of immune cell. A patient’s T cells are extracted and cryogenically frozen so that they can be transported to Novartis’s manufacturing center in New Jersey. There, the cells are genetically altered to have a new gene that codes for a protein—called a chimeric antigen receptor, or CAR. This protein directs the T cells to target and kill leukemia cells with a specific antigen on their surface. The genetically modified cells are then infused back into the patient. In a clinical trial of 63 children and young adults with a type of acute lymphoblastic leukemia, 83 percent of patients that received the CAR-T therapy had their cancers go into remission within three months. At six months, 89 percent of patients who received the therapy were still living, and at 12 months, 79 percent had survived.

David Mitchell, founder of an advocacy group called Patients for Affordable Drugs, said in a statement that the $475,000 cost is “excessive” and claims the federal government spent $200 million in early research on CAR-T therapy before Novartis purchased rights to the treatment. The group recently met with the company to appeal for a “fair” price for its therapy. Previous estimates predicted a price tag between $600,000 to $750,000.

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#1

Re: Engineering Immune Cells to Fight Cancer - FDA Approved!

09/06/2017 10:10 AM

nice post.

Microbiology is exploding with advances ( thanks CRISPER) the changes are rapid. for several years the 3 letters of G M O have carried a forbidden connotation . I have a feeling in the coming years this will complete a 180.

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The Engineer
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#2
In reply to #1

Re: Engineering Immune Cells to Fight Cancer - FDA Approved!

09/06/2017 10:32 AM

The results do seem remarkable. The trick would be getting this to work for other types of cancers, but if they could...that would be amazing!

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#3

Re: Engineering Immune Cells to Fight Cancer - FDA Approved!

09/06/2017 11:26 AM

The good news is, we might be able to cure your cancer....the bad news, you can't afford it....

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#4
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Re: Engineering Immune Cells to Fight Cancer - FDA Approved!

09/06/2017 11:56 AM

Maybe not. My step daughter has MS. Her drugs would cost $60K a year, $10K more than she earns.

With the help of my wife (30 year health care professional) and her doctor, she gets her drugs free of charge from the drug company. I expect that all drug makers have similar policies.

It might be worth a look-see for new cancer sufferers. For old guys like me who have already had organs and body parts removed, it's too late.

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#5
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Re: Engineering Immune Cells to Fight Cancer - FDA Approved!

09/06/2017 12:08 PM

It's like a lot of other things, the early adopters pay for the R&D. Eventually, the price will drop as very smart people figure out how to do it more economically. (Genetic testing is much cheaper now than when it was first developed.)

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#6
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Re: Engineering Immune Cells to Fight Cancer - FDA Approved!

09/06/2017 12:34 PM

Epi-Pens™ and insulin don't seem to be following those trends, quite the contrary.

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#19
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Re: Engineering Immune Cells to Fight Cancer - FDA Approved!

09/10/2017 1:14 AM

From what I understand this was government funded initially to the tune of 200 million dollars...so we have in fact already paid for the lions share of R&D...

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#8
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Re: Engineering Immune Cells to Fight Cancer - FDA Approved!

09/06/2017 1:41 PM

...and the even worse news...the stuff you eat is causing your cancer...and "we" put it on your table...

Sorry, I don't believe any of this is worth its weight in salt.

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#7

Re: Engineering Immune Cells to Fight Cancer - FDA Approved!

09/06/2017 1:40 PM

Interesting, but was there a control group that also demonstrated similar survival rates?

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#9
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Re: Engineering Immune Cells to Fight Cancer - FDA Approved!

09/06/2017 4:29 PM

Yes but the ones that survived were found to have faux cancer, that's where you were diagnosed with cancer because of certain markers found in your blood, turns out the markers can be caused by several different conditions, but just to be safe you get diagnosed with cancer so they can begin expensive treatment,,,just in case...so they were the ones that survived...without treatment

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#10
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Re: Engineering Immune Cells to Fight Cancer - FDA Approved!

09/06/2017 4:40 PM

Double Yikeys, Batman! Are you seriously brave enough to be outing the Beeg Pharma?

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#11
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Re: Engineering Immune Cells to Fight Cancer - FDA Approved!

09/06/2017 4:50 PM

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#12
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Re: Engineering Immune Cells to Fight Cancer - FDA Approved!

09/06/2017 4:59 PM

Aw man! Wow!

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#13
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Re: Engineering Immune Cells to Fight Cancer - FDA Approved!

09/06/2017 11:11 PM
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#14
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Re: Engineering Immune Cells to Fight Cancer - FDA Approved!

09/06/2017 11:40 PM

http://tucson.com/news/local/arizona-s-health-chief-seeks-limits-on-opioid-prescriptions/article_e861b669-bc8d-5876-885b-a0f9c48f6596.html

We want to save the junkies by making everybody suffer....I guess if people start overeating they'll want to ration food...wait that's already happening...maybe they'll just start arresting fat people and putting them in "detention centers" where they are put on strict rationing...bread and water? If they could just pass a law against aging I think this would all work itself out.....

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#17
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Re: Engineering Immune Cells to Fight Cancer - FDA Approved!

09/07/2017 8:44 AM

I think they already passed a law against breathing in certain areas. I simply avoid those areas. When the "authorities" decide my lifestyle is against the law, when they come for me, they will in fact find an outlaw.

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#15
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Re: Engineering Immune Cells to Fight Cancer - FDA Approved!

09/06/2017 11:47 PM

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The Engineer
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#16

Re: Engineering Immune Cells to Fight Cancer - FDA Approved!

09/07/2017 8:06 AM
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#18
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Re: Engineering Immune Cells to Fight Cancer - FDA Approved!

09/07/2017 8:47 AM

I would say that appears to be no obstacle for Big Pharma. They have been killing people for years now. Are you saying they will curtail this one because the action is so quick, they cannot harvest profits from it?

Two words never to use in the same sentence with Big Pharma: (1) efficacy, and (2) compassion.

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