Posted by Michael Wonder on 21 Nov 2017
FDA approval of tisagenlecleucel
21 November 2017 - Promise and complexities of a $475, 000 cancer drug.
Approval of the drug tisagenlecleucel (Kymriah; Novartis) by the US FDA for the treatment of paediatric and young adult acute lymphoblastic leukaemia 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.
