FDA approves cutting-edge cancer treatment for ‘patients without hope’

(WSVN) - The U.S. Food and Drug Administration has approved a gene-altering treatment for some patients with aggressive forms of blood cancer, after an FDA panel unanimously recommended approval back in July.

The drug – called Yescarta – genetically reboots a patient’s immune cells to kill the cancer. Scientists call it a “living drug” that boosts a patient’s own immune system to attack the disease.

Dana Farber Cancer Institute and Brigham and Women’s Hospital conducted studies for the drug.

The treatment, called CAR T-cell therapy, which removes millions of T-cells from a patient so they can be genetically engineered. 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.

In tests, Yescarta was given to 101 patients. Approximately 72 percent saw their cancer shrink, while half showed no sign of the disease eight months later. However, three people died after getting the treatment.

The new therapy is approved for adults that already had two unsuccessful regimens of chemotherapy. Those patients have generally run out of options, and have a very small chance of remission.

“This is really an exciting advance for patients without hope,” Dr. Frederick Locke told WESH. Lock is the director of research for the Immune Cell Therapy Program at Moffitt Cancer Center in Tampa, and helped run patient tests of the drug.

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.

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