Cancer-killing drug approved, but will you be able to afford it?

Graphic on an immunotherapy treatment for acute lymphoblastic leukemia a process that gained approval for use in the United States Wednesday. AFP

There are several types of ACT (see "ACT: TILs, TCRs, and CARs"), but the one that is closest to producing a treatment approved by the Food and Drug Administration (FDA) is called vehicle T-cell therapy.

"We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer", says FDA Commissioner Scott Gottlieb in a statement.

David Mitchell, president of Patients For Affordable Drugs, said: "While Novartis's decision to set a price at $475,000 per treatment may be seen by some as restraint, we believe it is excessive".

Dr. Len Lichtenfeld, deputy chief medical officer of the American Cancer Society, is excited by the drug's approval, but he has some reservations. "There is still much more work to do", Lichtenfeld told Healthline. "I think this is just the beginning of a new era of gene therapy".

The treatment, called Kymriah, aims to give some patients a second chance after first-line drugs have failed.

To start, a doctor removes some of a patient's white blood cells, the part of our body's immune system responsible for combatting infections and foreign substances. "It's shown a massive response rate in people with these cancers". They are then reintroduced back into the patient to do battle against the tumor.

While that is the only time the treatment's given, it's not the end of the road. Is this going to be a cancer cure only available to the rich? The worst is cytokine release syndrome, a common immunotherapy complication that causes potentially life-threatening fever and flu-like symptoms.

Analyst estimates put the cost of goods at roughly $200,000 a patient.

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The approval was widely expected after an FDA advisory panel last month unanimously recommended the action. But while the treatment is complex, it offers huge rewards.

"Expect turbulent public discussions on drug pricing, demonstrating that the road to hell is paved with good intentions", said Bruno Bulic of equity research firm Baader Helvea. "It's a great accomplishment".

Cancer cells are seen on a large screen connected to a microscope at the CeBit computer fair in Hanover, Germany, March, 6, 2012. The treatment is the first of its kind approved in the U.S. Gilead Sciences this week announced an $11.9 billion deal to buy Kite Pharma to gain access to a similar drug, while Bluebird Bio and Juno Therapeutics are all working on their own CAR-T therapies.

Novartis points out that some groups think the company could actually have charged more for Kymriah.

Those early-stage clinical trials, in which more than 90 percent of patients achieved a complete remission one month after receiving the therapy, led to a global registration trial in 2015, involving 68 children and young adults with advanced ALL treated at 25 centers across the world.

"More research is needed to make this therapy more effective for a broader population, to reduce the severe side effects that patients experience during treatment, and ultimately to find a broader application beyond blood cancers", he said.

Other trials with CTL019 therapy are also underway in the Abramson Cancer Center for adult ALL patients and those with CLL and non-Hodgkin lymphoma.

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