FDA Approval of Tisagenlecleucel as CAR-T Therapy for Leukemia | Clinical Pharmacy and Pharmacology | JAMA | The JAMA Network

FDA Approval of Tisagenlecleucel as CAR-T Therapy for Leukemia | Clinical Pharmacy and Pharmacology | JAMA | The JAMA Network

September 20, 2017

FDA Approval of TisagenlecleucelPromise and Complexities of a $475 000 Cancer Drug

Peter B. Bach, MD¹; Sergio A. Giralt, MD¹; Leonard B. Saltz, MD¹

Author Affiliations Article Information

JAMA. Published online September 20, 2017. doi:10.1001/jama.2017.15218

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Approval of the drug tisagenlecleucel (Kymriah; Novartis) by the US Food and Drug Administration (FDA) for the treatment of pediatric and young adult acute lymphoblastic leukemia (ALL) in August 2017 was a landmark in oncology. The science underlying chimeric antigen receptor T cells (CAR-T) heralds a new era of treatment, and the list price of $475 000 for the new drug (delivered as a one-time infusion) definitively shattered oncology drug pricing norms.¹