Pioneering cancer treatment a 'bargain' at $600000, says drug giant

Pioneering cancer treatment a 'bargain' at $600000, says drug giant

Pioneering cancer treatment a 'bargain' at $600000, says drug giant

The agency called it a "historic action", as it is a first approval of its kind for a gene therapy.

The FDA approved Kymriah, which scientists refer to as a "living drug" because it involves using genetically modified immune cells from patients to attack their cancer.

"We're very comfortable" with the price, said Bill Hinshaw, head of the company's USA cancer business. "The therapies that we're using to treat children 20 years from now will emerge from the investment in science that we make today". A clinical trial found 83 percent of patients who underwent the treatment went into remission within three months. The illness is the most common cancer for children in the USA with the National Cancer Institute estimating around 3,100 patients less than 20 years of age diagnosed each year.

Novartis' product, Kymriah, is the first gene therapy approved in the U.S. It belongs to a new class of treatment known as CAR-T therapy.

This Wednesday, the Food and drug administration (FDA) the u.s. equivalent of MSNA, has approved the first gene therapy against cancer. "While Novartis' decision to set a price at $475,000 per treatment may be seen by some as restraint, we believe it is excessive".

"In the next few years", he said, "I think we're going to see dramatic progress and push the boundaries of what many people thought was possible with these adoptive cell transfer-based treatments".

A spokeswoman for Switzerland-based Novartis declined to say how much the drug will cost, though analysts have estimated a price of $500,000 or more.

"The CAR T cells, they find the cancer cells, and the cancer cells can not hide anymore".

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"The FDA is requiring that hospitals and their associated clinics that dispense Kymriah be specially certified", it added.

"We're excited and proud to have moved this vehicle therapy, in collaboration with Novartis and CHOP, through all phases of development and clinical trials, established its efficacy, and now extended its reach to children across the country under this FDA approval", he added.

But there are drawbacks - the main one being the price tag. Most ALL patients respond to initial therapy, but Kymriah will be an invaluable back-up option for relapsed and refractory patients who now have poor prognosis. The worst is cytokine release syndrome, a common immunotherapy complication that causes potentially life-threatening fever and flu-like symptoms.

For now, Kymriah is only available to a small subsection of cancer patients.

The FDA has taken necessary steps to check the side effects that are generated due to the CAR-T treatment.

Devoe also said that while the positive results are exciting, many questions remain about how long these novel cancer treatments - developed mainly in the past decade or so - will last.

Other genetic therapies for cancer are also in the research pipeline. "While payers are developing their coverage policies for [tisagenlecleucel], we will offer an access program in the United States for eligible uninsured or underinsured patients".

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