FDA approves 2nd gene therapy targeting non-Hodgkin lymphomas

Posted on: Sat 21-10-2017

The US Food and Drug Administration has approved a second gene therapy for cancer, the first to target non-Hodgkin lymphomas.

The therapy, Yescarta (axicabtagene ciloleucel), is intended for adult patients with certain types of large B-cell lymphoma after other treatments fail.

Non-Hodgkin lymphomas, which account for about 4% of all cancers in the United States, are malignancies that begin in certain cells of the immune system. An estimated 72,000 new cases are diagnosed each year in the US.

Diffuse large B-cell lymphoma, which is the most common form of non-Hodgkin lymphoma, represents about one in three newly diagnosed cases.

Currently, up to half of all patients with large B-cell lymphoma relapse or become resistant to treatments, which may include chemotherapy, stem cell transplants, and immunotherapy.

Dr. Scott Gottlieb, commissioner of the FDA, noted in a statement announcing the approval Wednesday, how gene therapy has "gone from being a promising concept to a practical solution" for treating deadly forms of cancer in just several decades. He called the approval a "milestone."

The new drug is made by California-based Kite, a subsidiary of drug giant Gilead Sciences that develops chimeric antigen receptor and T-cell receptor (CAR-T) cell therapies. These new treatments use a patient's own T-cells to seek and destroy cancer cells.

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