FDA advisers back Novartis’ game-changing personalized CAR-T for cancer, approval in sight
The FDA’s advisory committee on cancer drugs has offered a group thumbs-up for Novartis’ trailblazing CAR-T CTL019 (tisagenlecleucel), marking a key milestone for the pharma giant as it nears the likely launch of a groundbreaking personalized cell therapy for B-cell acute lymphoblastic leukemia.
These outside experts at the FDA voted 10 to 0 to urge an approval for this drug, offering some key support after regulators carefully reviewed the complex manufacturing process as well as the safety and efficacy profiles of this therapy.
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