Novartis’ just-approved chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) is going to be introduced on the market at a price of 5,000 for a single infusion, an amount that is within the range anticipated by oncologists and that Novartis characterized as well below a price level that could be justified on cost.
Tisagenlecleucel is a genetically modified autologous T-cell immunotherapy. Each dose is a customized treatment created with a patient’s own T-cells, which are collected and sent to a manufacturing center where they are genetically modified to include a new gene that contains a specific protein—a chimeric antigen receptor or CAR—that directs the T-cells to target and kill leukemia cells that have a specific antigen (CD19) on the surface. Once the cells are modified, they are infused back into the patient to kill the cancer cells.
Novartis estimates that the turnaround time for processing the cells is 22 days, and initially the FDA has approved one manufacturing site for conducting this work: Novartis’ Morris Plains, New Jersey, laboratory. Whereas the time involved in processing is considered critical because of the need for rapid treatment of patients, Novartis has a cryogenic process that enables it to freeze and store samples of patients’ blood cells for processing at more convenient times and earlier during the treatment cycle.
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