American CAR-T Leader Eyes Europe, Initiating Market Approval Process & Clinical Trial

08/08/2017 - 2 minutes

Kite is charging ahead in Europe with a clinical trial and marketing authorization application as Novartis leads in the American CAR-T race.

Novartis has claimed the position as the frontrunner in the CAR-T race, having just earned the unanimous recommendation of the FDA for the approval of CTL019, christened tisagenlecleucel. However, its lead is far from decisive: the American biotech, Kite Pharma, is hot on the heels of the Swiss pharma, and now it’s encroaching on Novartis’ territory with a clinical trial and market approval application in Europe.

Kite announced yesterday that the first patient has been dosed with its lead CAR-T candidate, axicabtagene ciloleucel, in a European safety expansion of its ZUMA-1 trial for various lymphomas. It’s hardly exciting news, but the company seems intent on making a lot of noise about its activities on the continent: Last week, it submitted a marketing authorization application to the EMA.

This application is the first for a CAR-T therapy in Europe. Novartis has yet to make its approach, despite Europe being its home turf, but the pharma plans to do so later this year.

Statement from Kite on Novartis’ FDA hearing, which was the first of its kind for CAR-T therapies.

The EMA granted Kite PRIME designation for the treatment of refractory diffuse large B-cell lymphoma (DLBCL) after it received Breakthrough Therapy Designation from the FDA. Despite this regulatory love and a response rate comparable to that of Novartis’ drug, Kite has run into a number of patient deaths from neurotoxicity that have slowed its progress.

For Juno, this meant the end of the road — the company jettisoned its program earlier this year — but Kite is carrying on. Perhaps as Novartis seizes the American market, Kite can prove itself on its European counterpart.

Image via Zurijeta / ; Kite Pharma / LinkedIn

Do you want to remove this advert? Become a member!
Do you want to remove this advert? Become a member!

Support Us

Become a Member