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FDA approves breakthrough treatment for dire cancers

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Novartis won FDA approval for its CAR-T drug Kymriah on Wednesday

The Food and Drug Administration on Wednesday approved the first CAR-T therapy, ushering in a new approach to treating cancer in a landmark decision for the rapidly advancing field of cell therapy.

The company did say that it's made an agreement with the USA government to pay for the drug only when pediatric or young adult patients with the cancer respond to treatment by the end of their first month.

Scientists often refer to this type of gene therapy as a "living drug" because it involves using genetically modified immune cells from patients. Once the cells are modified, they are infused back into the patient to kill the cancer cells. In the pivotal Novartis trial, 83 percent of patients achieved remission with a disease that has historically poor outcomes.

Kymriah, a cell-based gene therapy, is approved in the United States for the treatment of patients up to 25 years of age with B-cell precursor ALL that is refractory or in second or later relapse. At the Novartis FDA panel, parents told their children's stories and pleaded with the committee to recommend the med.

Novartis' CAR-T, which will be marketed as Kymriah, leads an emerging field of cell therapies created to engineer the body's immune cells to seek out and destroy cancers.

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

With the treatments available now, fewer than 10 percent of patients with the relapsed, hard-to-treat leukemia are alive five years after diagnosis. CAR-T cell therapy gives patients stronger T cells to do that job. Pharma critics including KEI director Jamie Love and Patients for Affordable Drugs President David Mitchell have said that, because taxpayers funded early research, the public should be guaranteed affordable pricing. Novartis expects to have 32 centers around the country, mostly in large cities, running by year's end, with the first 20 offering care within the next month.

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Because of these safety concerns, the FDA will require that hospitals receive special certification to use Kymriah, the agency said.

For some patients, the new CAR-T therapy might replace bone marrow transplants that cost more than half a million dollars, noted Grupp, who led the Novartis study.

Novartis officials said they will offer a patient assistance program to help people with out-of-pocket costs.

Manufacturing and delivery are more complex in CAR-T therapies than for a typical drug.

On Wednesday, the FDA also expanded approval for another drug, tocilizumab, to treat CRS in patients 2 and older.

This approval has sent shock waves throughout the cancer community.

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