FDA approves Yescarta from Gilead's Kite

FOSTER CITY, Calif. — The Food and Drug Administration has approved the first chimeric antigen receptor T cell, or CAR T, therapy for patients with certain types of lymphoma. Yescarta, from Gilead’s recently acquired company Kite, was approved to treat relapsed or refractory large B-cell lymphoma following two or more lines of systemic therapy.

“The FDA approval of Yescarta is a landmark for patients with relapsed or refractory large B-cell lymphoma. 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. “We must also recognize the FDA for their ability to embrace and support transformational new technologies that treat life-threatening illnesses. We believe this is only the beginning for CAR T therapies.”

Diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma, representing 1-in-3 of the roughly 72,000 new cases diagnosed every year in the United States. Each dose of Yescarta is customized based on a patient’s immune system to help fight the immune system. A patient’s T-cells are collected and genetically modified to include a new gene that targets and kill lymphoma cells. The list price of Yescarta, according to Gilead, is $373,000.

The approval comes as the FDA is set to offer more guidance to manufacturers on the development of gene therapies similar to Yescarta.

"Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases. 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," FDA commissioner Dr. 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. We will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine. That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR-T cells and other gene therapies.”