FDA panel recommends approval of gene-altering therapy to fight cancer

(WSVN) - A U.S. Food and Drug Administration panel has unanimously recommended that the agency approve a cutting-edge cancer therapy.

It’s a first-of-its-kind treatment, which genetically alters a patient’s own cells to fight cancer. Scientists call it a “living drug” that boosts a patient’s own immune system to attack the disease.

Several drug companies are working on the treatment, called CAR T-cell therapy, which removes millions of T-cells from a patient so they can be genetically engineered, according to Fox 13. The cells are then reprogrammed to create an army of cells to recognize and destroy cancer.

The modified T-cells are then infused back into the body and they are designed to find and kill cancer cells. These new T-cells capable of killing thousands of cancer cells, and a single turbocharged cell can destroy up to 100,000 cells.

To use the technique, a separate treatment must be created for each patient — their cells removed at an approved medical center, frozen, shipped to a Novartis plant for thawing and processing, frozen again and shipped back to the treatment center.

Healthcare company Novartis presented their data to the FDA panel earlier this month, showing their work on acute lymphoblastic leukemia in children and young adults. Scientists are first focusing on leukemia, since it is a cancer of the blood, before working on other forms of cancer in the body, Bloomberg reports.

Novartis presented a study of 63 patients who received the treatment for the severe cancer over the course of 16 months. Of those patients, 52 of them (or 82.5 percent) went into remission, a high rate for the disease, the New York Times reported. Eleven of the patients died.

The treatment has its risks: while no one died from the therapy during the Novartis trials, several patients in other trials passed away due to cerebral edema, where excessive fluid causes swelling in the brain. A young girl who was the first child to undergo the experimental treatment in 2012 suffered severe side effects that nearly killed her, including high fevers, lung congestion and dramatic blood pressure swings. But she survived and has remained cancer-free; she appeared at the FDA’s panel to advocate for its approval.

Analysts estimate the one-time treatment could cost over $300,000. While that may seem high, patients with cancer often face years of expensive treatment and hospital stays, which could end up costing even more.

Michael Werner, a lawyer and expert on gene and cell technologies and regulation, said that results so far proved that T-cell treatment works.

“The fact that it can be done means more people will go into the field and more companies will start developing these products,” he said, adding, “I think we’re in for really exciting times.”

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