BLA Accepted: Novartis Inches Ahead In CAR-T Race With Kite
Executive Summary
Novartis may very well have the first CAR-T therapy approved in the US, beating its rival Kite Pharma to the finish line, since the FDA has accepted the Swiss big pharma's BLA for priority review. Kite says it will complete its rolling BLA submission in a different indication by the end of March.
You may also be interested in...
Cellectis Moves First Off-The-Shelf CAR-T Into US Clinical Trials
UCART123 is behind the initial wave of CAR-T drugs for cancer but could have a big advantage as an allogeneic, or off-the-shelf, option. A Phase I trial is now under way in patients with acute myeloid leukemia.
Killer Cures: Industry Heavyweights Make Their Presence Felt In Cell And Gene Therapy
Cell and gene therapies, described as the most exciting developments in the life sciences industry, pick up more momentum with every passing month. The spiraling enthusiasm for an activity that will change how health care is delivered was captured by GE, GSK and other key industry players at a leading UK life sciences industry meeting in spring 2017.
Much Anticipated JULIET Data Show Novartis Playing Catch-Up On CAR-T Manufacturing
Novartis reported positive early results for its lead CAR-T candidate CTL019 in DLBCL that appear to be consistent with Kite's competing therapy in the same indication, but the data show the Swiss big pharma ran into manufacturing issues that weren't resolved until later in the JULIET study.