20 October 2016 - During a Q&A session with Wall Street analysts, CEO Arie Belldegrun was thrilled when an audience member asked what the company has been doing to secure insurance reimbursement for KTE-C19, its experimental cancer treatment made from engineered immune cells called T-cells.
Belldegrun was happy because a year ago, no one was talking about potential insurance scrutiny. Instead, most of the questions centered around whether Kite would have robust enough data to prove to the FDA that the cells work, and if it would ever be able to manufacture them in a scalable way.
Now Kite is preparing to file for FDA approval of KTE-C19, its lead chimeric antigen receptor T-cell (CAR-T), to treat patients with diffuse large B-cell lymphoma. The treatment involves extracting T-cells from the blood of individual patients and re-engineering them so they are able to recognise cancer cells and eradicate them—work that will be done in a 45,000-square-foot facility Kite built near its Los Angeles headquarters.
The company hopes to make the filing by the end of this year, which would put it ahead of rivals Juno and Novartis.