With the application review hearing set for tomorrow, the FDA has shared its thoughts on Novartis’ CAR-T candidate. Up front are serious safety concerns.
Novartis’ CTL019, or Tisagenlecleucel, wowed the audience at ASH last fall with a stellar 82% response rate in B-cell acute lymphoblastic leukemia (ALL), prompting its developer to beeline to the FDA with a BLA of what may well be the first CAR-T therapy on the market. Ahead of the committee’s hearing tomorrow, which will be live-blogged by STAT News, the FDA has released findings from its review: efficacy doesn’t seem to be a problem, but long-term safety has caused some concern.
