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Government regulators approve 2nd gene therapy for blood cancer

Trenton, NJ — U.S. regulators on Wednesday approved a second gene therapy for a blood cancer, a one-time, custom-made treatment for aggressive lymphoma in adults.

The Food and Drug Administration allowed sales of the treatment from Kite Pharma.

It uses the same technology, called CAR-T, as the first gene therapy approved in the U.S. in August, a treatment for childhood leukemia from Novartis Pharmaceuticals.

“In just several decades, gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer,” FDA Commissioner Dr. Scott Gottlieb said in a statement.

The treatment, called Yescarta, will cost $373,000 per patient, according to drugmaker Gilead Sciences.

Kite became a subsidiary of Foster City, California-based Gilead this month.

CAR-T treatment uses gene therapy techniques not to fix disease-causing genes but to turbocharge T cells, immune system soldiers that cancer can often evade.

The T cells are filtered from a patient’s blood, reprogrammed to target and kill cancer cells, and then hundreds of millions of copies are grown.

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