stay tuned:
elixi news from the
world

FDA Grants Priority Review for Kite’s KTE-X19 Biologics License Application (BLA) in Relapsed or Refractory Mantle Cell Lymphoma

FDA Grants Priority Review for Kite’s KTE-X19 Biologics License Application (BLA) in Relapsed or Refractory Mantle Cell Lymphoma

Kite, a Gilead Company has announced that the U.S. Food and Drug Administration has accepted the Biologics License Application (BLA) and granted Priority Review designation for KTE-X19, an investigational chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

The BLA is supported by data from the single arm, open-label, Phase 2 ZUMA-2 trial, which showed that 93 percent of patients responded to a single infusion of KTE-X19, including 67 percent of patients achieving a complete response, as assessed by an Independent Radiologic Review Committee (IRRC; median follow-up of 12.3 months).

Detailed findings from this trial were recently presented during an oral session at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando.

“Despite recent advances, patients with relapsed/refractory mantle cell lymphoma currently face a significant lack of effective treatment options once their disease no longer responds to currently available therapy,” said Ken Takeshita, MD, Kite’s Global Head of Clinical Development. “Based on the encouraging results for KTE-X19, we are eager to continue discussions with the FDA on how to bring this innovative treatment to these patients who may benefit from CAR T therapy.”

The European Medicines Agency (EMA) recently validated the Marketing Authorization Application for KTE-X19 in the European Union.

KTE-X19 is investigational and not yet approved in any country globally. Its efficacy and safety have not been established. A final decision by the FDA is anticipated by August.

MCL is a rare form of non-Hodgkin lymphoma (NHL) that arises from cells originating in the “mantle zone” of the lymph node and typically affects men over the age of 60.

For more information and fast delivery of the life-saving, latest FDA approved oncology drugs, please contact us at info@elixi-int.com

We are a Swiss pharmaceutical wholesaler, specialised in sourcing and delivering pharma products, medical devices and drugs from and to all over the world

Share this article

Share on twitter
Tweet
Share on facebook
Share
Share on pinterest
Pin it
Share on linkedin
Share

SEE Also

we are specialized in the procurement and distribution of pharmaceutical products, medical devices all over the world

Stay Tuned

Subscribe to our newsletter

Contact us

ELIXI International SA

Vicolo Oldelli 1
6830 Chiasso / Switzerland
Email info@elixi-int.com
Phone/Fax +41 91 6822040

ELIXI International SA

Copyright 2019 ELIXI International SA.   |   All Rights Reserved   |   Privacy Policy   |   Cookie Policy   |   Credits ATG Suisse