Kite wins FDA approval for first adult CAR-T cell therapy

More than a month before it was due to make a decision, the FDA yesterday approved a CAR-T cell therapy from Kite Pharma (NSDQ:KITE) – the first of its kind for adults.

The therapy, which is made from a patient’s own cells, is designed to treat adults with non-Hodgkin lymphoma who have failed at least two other treatments.

The decision comes just two months after Gilead Sciences (NSDQ:GILD) paid $12 billion to acquire Kite. The company said yesterday that its CAR-T therapy, called Yescarta, will cost $373,000.

The Yescarta therapy is the second of its kind ever approved – the first was Novartis (NYSE:NVS), which won approval recently for its Kymriah therapy designed to treat acute lymphoblastic leukemia.

According to Yescarta’s official label, 72% of the 101 patients experienced a positive response after a one-time dose of cells and more than half had a complete response after nine months, according to Xconomy.

The nine-month data were better than the data collected from the same patients at three and six months. In other words, the cells seem to improve over time.

“This is going to change how we treat blood cancers and how we treat cancers in general,” Armin Ghobadi, an assistant professor of medicine at Washington University, told Xconomy.