Gilead ramping up auto T clinics after US FDA Yescarta approval

Retired Utah Jazz basketball player Thurl Bailey
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What distinguishes the Israeli-owned drug from other pharmaceuticals is that each dose offers a personalized treatment, made directly from the patient's own immune system to fight the lymphoma. There are approximately 72,000 new cases of National Hockey League diagnosed in the United States annually. To date, 100 patients have reportedly been treated with Yescarta.

Noting the FDA's commitment to "supporting and helping expedite" the development of gene therapies, Gottlieb said, "we will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine".

This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma. The FDA warns that axicabtagene ciloleucel has a boxed warning for cytokine release syndrome, which causes a high fever, flu symptoms, and neurological toxicities.

Gilead has listed axicabtagene ciloleucel at $373,000 in the United States, much cheaper than the launch price of tisagenlecleucel at $475,000. An estimated 72,000 new cases are diagnosed each year in the US.

Novartis, the company that makes Kymriah, is also working to get the drug approved in an aggressive form of lymphoma in adults, which could introduce some competition into the adult market. The treatment, called Yescarta, is the first immunotherapy on the U.S. market for certain kinds of non-Hodgkin lymphoma (NHL), a cancer that attacks the lymph nodes.

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The Food and Drug Administration has approved the first chimeric antigen receptor T cell, or vehicle T, therapy for patients with certain types of lymphoma. Also, patients must be informed of the potential serious side effects and of the importance of promptly returning to the treatment site if side effects develop.

"The acquisition of Kite establishes Gilead as a leader in cellular therapy and provides a foundation from which to drive continued innovation for people with advanced cancers", GILD CEO, John F. Milligan, Ph.D., said in a statement. "This approval would not have been possible without the courageous commitment of patients and clinicians, as well as the ongoing dedication of Kite's employees", Kite founder Dr. Arie Belldegrun said. In the United States each year, approximately 7,500 patients with refractory DLBCL are eligible for CAR-T therapy.

The product, which the FDA approved on a fast-track process, is based on innovative technology that recruits the body's immune system to identify and destroy cancer cells. "We believe this is only the beginning for auto T therapies".

"Today's approval of Yescarta is a very significant advance for lymphoma patients and for the cancer community as a whole", Louis J. DeGennaro, president of the Leukemia & Lymphoma Society, said in a statement.

Dr. David Maloney, medical director of cellular immunotherapy at Fred Hutchinson Cancer Research Center, helped develop the therapy and said the FDA's second approval of a CAR-T cell therapy "validates the revolution underway in the field of cellular immunotherapy".

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