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

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.

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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.

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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 / shutterstock.com ; Kite Pharma / LinkedIn

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