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

More from Immuno-oncology
Merck expects Keytruda to come under Medicare price controls in 2028, but an analyst said the subcutaneous version could shield revenues for the franchise.
J&J is confident that its bispecific antibody/kinase inhibitor combo’s overall survival win over AstraZeneca’s single-agent pill will shift the standard of care.
Increasingly focused on maximizing and accelerating the progress of its PD-L1 x VEGF inhibitor BNT357, the company expects new partnerships to be announced this year.
Sun is acquiring Checkpoint Therapeutics, opening up opportunities to build out its strategy in the onco-derm segment with the US firm’s FDA-approved anti-PD-L1 mAb.
More from Anticancer
J&J is confident that its bispecific antibody/kinase inhibitor combo’s overall survival win over AstraZeneca’s single-agent pill will shift the standard of care.
The Danish firm is spending nearly $580m to repurchase up to 2.2 million shares
Miltenyi’s leadership calls for a streamlined regulatory framework as India gears to scale in cell and gene therapy. Executives from the German group also talked to Scrip about helping advance local capabilities, delivering point-of-care CAR- T cell therapy to hospitals and pricing dynamics.