Gene-altering cancer drug approved as immunotherapy surges
The US Food and Drug Administration has given its approval for the Yescarta gene therapy from Kite Pharma to be used on aggressive forms of non-Hodgkin’s lymphoma. The treatment genetically alters a patient's immune cells, turning them into a “living drug”, to destroy the cancer. The immunotherapy, the second such treatment to get FDA backing, has led to long remissions in some cases, leading to the approval for patients who have already had two failed courses of chemotherapy. The cost of the treatment is $373,000 for the single infusion required. Side effects include fever, blood pressure drops, neurological problems and lung congestion.

The Food and Drug Administration on Wednesday approved the second in a radically new class of treatments that genetically reboot a patient’s own immune cells to kill cancer.

The new therapy, Yescarta, made by Kite Pharma, was approved for adults with aggressive forms of a blood cancer, non-Hodgkin’s lymphoma, who have undergone two regimens of chemotherapy that failed.

The treatment, considered a form of gene therapy, transforms the patient’s cells into what researchers call a “living drug” that attacks cancer cells. It is part of the rapidly growing field of immunotherapy, which uses drugs or genetic tinkering to turbocharge the immune system to fight disease. In some cases the treatments have led to long remissions.

“The results are pretty remarkable,” said Dr. Frederick L. Locke, a specialist in blood cancers at the Moffitt Cancer Center in Tampa, and a leader of a study of the new treatment. “We’re excited. We think there are many patients who may need this therapy.”