On August 30th, Novartis’ Kymriah was approved by the U.S. Food & Drug Administration for treating a form of ALL (acute lymphoblastic leukemia) in individuals age 25 and younger. Kymriah, or tisagenlecleucel is a CAR-T (Chimeric Antigen Receptor T-Cell) therapy that, according to reports, is a one-time treatment.

The treatment is customized to each patient, as his or her T-cells are collected before being sent to a production center where the T-cells are genetically modified to contain a new gene with certain CAR protein. The genetically modified cells reportedly then target and kill leukemia cells with the antigen CD19 once infused back into the patient.

A one-time treatment has a list price of $475,000 according to the company, who said the price of Kymriah therapy would be based on clinical outcomes. Novartis intends to work with Medicaid and Medicare to execute a pricing strategy, but said payment would be allowed only when acute lymphoblastic leukemia patients respond to the CAR-T cell therapy by the end of the first month.

Like most drugs, treatments, and therapies there is a risk of serious side effects according to reports, which may include neurological events and CRS, or cytokine release syndrome, which can be life-threatening and produces flu-like symptoms, along with high fever.

Hopefully this new therapy will be highly effective for young people who suffer from this type of ALL.

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