CAR-T Companies Hang Onto Novartis' Coat-Tails After Historic FDA Panel Vote
The FDA panel landmark recommendation for Novartis' CTL019 should provide a fillip for the other players in the CAR-T field but the response from the investment community has been lukewarm compared with researchers and patients.
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Kite Pharma may have been pipped to the post to be first with a CAR-T product at the US FDA, but it has sneaked in the first EU filing courtesy of PRIME for axicabtagene ciloleucel.
Kite Pharma claims it has filed the first EU application to market a CAR T-cell therapy, and says that being on the European Medicines Agency’s PRIME scheme was helpful when it came to getting answers to the questions it had on the application.
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.