New treatment OK’d for second cancer

Cutting-edge immunotherapy will cost $373,000

The Food and Drug Administration approved a second version of a groundbreaking treatment Wednesday that genetically alters patients’ cells to attack cancer, this time to fight aggressive non-Hodgkin lymphoma.

The treatment is for adults with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. The group numbers about 7,500 patients a year in the United States.

The one-time infusion, known as CAR T-cell therapy, is made by Kite Pharma. Kite announced Wednesday that the treatment’s brand name will be Yescarta and its price will be $373,000.

In late August, the FDA cleared the first CAR T-cell therapy, which is designed for children and young adults whose leukemia doesn’t respond to standard treatments.

The FDA approval is the latest step forward for the fast-moving field of immunotherapy, which aims to bolster the immune system to attack malignancies. “Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases,” FDA Commissioner Scott Gottlieb said in a statement, adding that the approval demonstrates “the continued momentum of this promising new area of medicine.”

A CAR T-cell therapy involves a complicated and customized procedure in which T cells, sometimes called the foot soldiers of the immune system, are removed from the patient. They are sent to a special lab and genetically modified to target a protein on the surface of the patient’s cancer cells. Once the modified cells are returned to the patient, their numbers expand exponentially as they become an army of cancer fighters.