Kite Pharma, founded by Israeli-American professor Arie Belldegrun in 2009, announced that the US Food and Drug Administration (FDA) has granted regular approval for its cancer treatment, Yescarta.
California-based Gilead Sciences bought Kite Pharma for $12 billion in August.
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 is approved for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of conventional therapy. To date, 100 patients have reportedly been treated with Yescarta.
The treatment is based on CAR-T therapy, which was developed by Israeli researchers at the Weizmann Institute of Science and the Tel Aviv Sourasky Medical Center. It represents a breakthrough in hematologic cancer treatment in which a patient’s own T cells are engineered to seek and destroy cancer cells. CAR-T therapy is customized for each patient.
“The FDA approval of Yescarta is a landmark for patients with relapsed or refractory large B-cell lymphoma,” Belldegrun said. “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. We believe this is only the beginning for CAR-T therapies.”