![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Kite Pharma Gains EU Conditional Authorization for Lymphoma Cell Therapy
Kite Pharma Gains EU Conditional Authorization for Lymphoma Cell Therapy
![KitePharma_Logo](https://www.fdanews.com/ext/resources/test/Drug-Images4/KitePharma_Logo.png?t=1582159316&width=430)
December 18, 2020
Gilead Sciences subsidiary Kite Pharma has secured conditional marketing authorization in Europe for the first cell therapy for relapsed or refractory mantle-cell lymphoma.
The authorization for the company’s chimeric antigen receptor (CAR) T cell therapy, Tecartus, was supported by positive data from a phase 2 study in lymphoma patients who were previously given an anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a Bruton Tyrosine Kinase enzyme inhibitor.
Participants showed an overall response rate of 93 percent, with 67 percent demonstrating a complete response, after receiving a single infusion of the therapy.
Upcoming Events
-
21Oct