The U.S. Food and Drug Administration has approved a second CAR-T treatment – hailed as a groundbreaking therapy that genetically alters cells to kill cancer cells – to treat non-Hodgkin lymphoma.
“Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases,” FDA Commissioner Scott Gottlieb said. “This approval demonstrates the continued momentum of this promising new area of medicine, and we’re committed to supporting and helping expedite the development of these products.”
Yescarta (axicabtagene ciloleucel), developed by Kite Pharma, is a chimeric antigen receptor (CAR-T) cell treatment used to treat adult patients with diffuse large B-cell lymphoma (DLBCL), a type of non-Hodgkin lymphoma – who have not responded to at least two other kinds of treatment.
What was just a promising concept several years ago is now a reality, the FDA said. Each Yescarta dose is created by collecting and genetically modifying a patient’s T-cells, a type of white blood cell, to include a new gene that targets and kills lymphoma cells. The modified cell is then infused back into the patient.
Kite announced the treatment would be priced at $373,000, according to foreign reports. Gilead Sciences bought the company based in Santa Monica, Calif., in August.
The approval was based on a multicenter clinical trial of more than 100 adults with refractory or relapsed large B-cell lymphoma that found the complete remission rate to be 51 percent after treatment. The tests also showed the drug could cause serious side effects such as cytokine release syndrome (CRS) and neurologic toxicities. The drug will carry the FDA boxed warning, which is the highest level warning the FDA can issue.
The agency also announced plans to release a comprehensive policy that supports the development of these cell-based regenerative medicines. The FDA approved Kymriah, the first CAR-T therapy from Novartis to treat leukemia, in late August.
About 72,000 people are diagnosed with non-Hodgkin lymphoma in the U.S. each year, it added.
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