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U.S. approves second gene therapy for blood cancer

U.S. approves second gene therapy for blood cancer

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

Other gene therapies for blood cancers are being tested and scientists think they may work for solid tumours within several years.

First gene therapy approved in the U.S

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.

Yescarta Treatment:

  • 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.
  • Yescarta, also known as axicabtagene ciloleucel, was approved for patients who have already been treated with at least two cancer drugs that either didn’t work for them or eventually stopped working.
  • Yescarta is not a benign treatment, though — three people died after getting the treatment, which can cause serious side effects. The FDA is requiring Kite to do a long-term safety study and train hospitals to quickly spot and handle those reactions.
  • Yescarta was given to 101 patients. About 72% saw their cancer shrink and about half showed no sign of disease eight months later.

A different type of gene therapy is waiting in the wings at the FDA. Spark Therapeutics’ treatment for a rare form of blindness could be approved within months. It aims to improve vision by replacing a defective gene needed to process light.

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