D-day: Novartis arrives at a crossroad in the blockbuster race to win the first FDA OK for CAR-T
Three years of intense competition and billions of dollars in investments into developing the world’s first CAR-T therapy has come down to the wire today with the first FDA panel review for Novartis’ leading CTL019 (tisagenlecleucel) therapy.
Observers crowded into the presentation room this morning, rubbing shoulders with CAR-T celebs like Penn’s Carl June with many, many more looking online as Novartis and regulators began the painstaking process of breaking down the manufacturing process that goes into the lengthy and complex task involved in making these drugs. While most of these panel reviews come down to assessing the data and how results stack up against the gold standard on safety and efficacy, the agency today wants their experts to carefully consider if these drugs can consistently be made to order in a safe fashion by manufacturers who are still fine tuning their delivery times. In addition, they’ll need to discuss the potential threat of a toxicity profile that has yet to be fully established or completely understood.
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