Kite has announced the validation of its Marketing Authorisation Application (MAA) for KTE-X19 by the European Medicines Agency (EMA).
The Gilead owned company has revealed that investigational chimeric antigen receptor CAR-T cell therapy is now under investigation by the body for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
According to Kite, the MAA is supported by data from the single arm, open-label, Phase II ZUMA-2 trial, which demonstrated an overall response rate of 93% and a 67% complete response rate.
The investigational drug has also been granted Priority Medicines (PRIME) designation by the EMA, but is not yet approved anywhere globally.
“Relapse rates in mantle cell lymphoma remain overwhelmingly high and there is a significant need for new therapies that may improve patients’ prognosis,” said Ken Takeshita, Kite’s global head of clinical development.
The filing marks Kite’s second CAR-T cell therapy, potentially expanding the company’s cell therapy portfolio.
In December last year, the company filed the CAR-T therapy with the US Food and Drug Administration (FDA), again based on the Phase II trial, raising hopes for the first such treatment for mantel cell lymphoma.
