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Novartis' CAR-T Poised For The Market After Unanimous FDA Adcomm Review

 
• By Jessica Merrill

FDA's Oncologic Drugs Advisory Committee recommends 10-0 the agency approve Novartis' tisagenlecleucel (CTL019) for pediatric leukemia in a panel review that was hailed by some in the industry as historic.

Destruction of leukaemia cell, conceptual image. 3D illustration which can be used to illustrate blood cancer treatment

FDA's Oncologic Drugs Advisory Committee recommended FDA approve Novartis AG's tisagenlecleucel (CTL019) July 12, all but guaranteeing the drug will be the first chimeric antigen receptor T cell (CAR-T) therapy to reach the market. The focus now for Novartis and investors will be on how the company will turn its CAR-T platform into a commercial success story.

Assuming approval, the company will initially focus distribution on a few dozen treatment centers, to address safety and provider training issues

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