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.