CAR-T

Kite shoots for first CAR-T OK in Europe, staying one step behind Novartis in US race

Arie Belldegrun


Kite Pharmaceuticals quite likely will come in a close second behind Novartis as they push their CAR-T drugs out into the crucial US market — but it still plans to be first mover in Europe.

This morning LA-based Kite says it was first in line at the EMA with an application for axicabtagene ciloleucel — axi-cel — as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL).

The two CAR-Ts have been under intense scrutiny for the past two years as Novartis and the much smaller Kite hustled along personalized cell therapies that take T cells from patients and equips them with chimeric antigen receptors so they can hunt down cancer cells. Kite is using ZUMA-1 data, which include a remarkable 82% overall response rate.

While CAR-T has a dangerous side effect profile which includes neurotoxocity as well as common cases of cytokine release syndrome, it has also proven to be a life saver for a significant group of patients who take them.

“The MAA submission of axicabtagene ciloleucel marks an important global milestone in the development of engineered T cell therapy,” said Kite CEO Arie Belldegrun in a statement.

Belldegrun last popped up to congratulate Novartis for its advances with CTL019, seemingly poised for a near-term approval after a positive panel review and its own stellar data. (All we know from Novartis at this point is that a European application will be filed later this year.) At the time, Belldegrun noted that the push to win a pioneering approval wasn’t a horse race.

That doesn’t mean he doesn’t like to come in first.


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RAPS Regulatory Convergence 2017