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.
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 33,100+ biopharma pros who read Endpoints News by email every day.Free Subscription