The therapy, Yescarta (axicabtagene ciloleucel), is intended for adult patients with certain types of large B-cell lymphoma after other treatments fail. Each treatment is customized using a patient's own immune cells to fight cancer cells. These are then sent to a facility in El Segunda, California - which Kite opened in June a year ago - where they are stimulated to proliferate and transduced with a retroviral vector to introduce the auto sequence into the patient's T cells before being propagated in cell culture bags.
"Engineered cell therapies like Yescarta represent the potential for a changing treatment paradigm for cancer patients", said David Chang, MD, PhD, worldwide head of research and development and chief medical officer at Kite, in a company press release.
Because of these risks, the FDA has approved Yescarta with a risk evaluation and mitigation strategy (REMS), which includes a requirement that hospitals and clinics be specially certified before dispensing the therapy.
Yescarta is the second CAR-T treatment approved by the FDA.
The FDA is also requiring that Kite continue to conduct observational studies of patients treated with Yescarta. Cytokine release syndrome occurred in 13% of patients and neurologic events were experienced by 28% of patients.
Axi-cel is the second vehicle T-cell therapy approved by the FDA, with the first, labeled tisagenlecleucel (Kymriah), approved in late August for patients with acute lymphoblastic leukemia, a rare blood cancer commonly affecting children.
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All patients had chemorefractory disease and had received a median of 3 prior lines of therapy, with 54% refractory to 2 consecutive lines of therapy.
Diffuse large B-cell lymphoma is the most common type of the disease in adults, with some 72,000 new patients diagnosed annually in the United States, according to the American Cancer Society, and some 20,000 will die from it this year. "In just several decades, gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer", said FDA Commissioner Scott Gottlieb, MD.
For more on what role pharmacists can play for patients with lymphoma, view the video below. Almgren was not involved in development of the new therapy. "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. This is the first gene therapy to be approved for non-Hodgkin lymphoma (NHL), according to the FDA. FDA made waves when it announced earlier this year.
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.
Yescarta was initially developed by researchers at the National Cancer Institute in Washington, DC. He said, "There will likely be thousands of lives saved in the next few years because of it".