First FDA-approved genetic therapy fights leukemia

Novartis won FDA approval for its CAR-T drug Kymriah on Wednesday

Kymriah (tisagenlecleucel; Novartis), the first chimeric antigen receptor T cell (CAR-T) therapy, is indicated to treat patients up to 25 years old with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.

The new treatment involves removing immune cells called T cells from a patient's blood and giving them a gene for a protein called a chimeric antigen receptor, or auto, that directs the T cells to target leukemia cells.

"We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer", said FDA Commissioner Dr. Scott Gottlieb.

Treatment with the therapy, developed by Swiss pharma Novartis AG, led to remarkable results in children with an aggressive form of leukemia resistant to other drugs.

Based on available data, patients on the treatment have had an 89% chance of surviving at least six months and a 79% chance of surviving at least a year, with most being relapse-free at that point.

"We are so proud to be part of this historic moment in cancer treatment and are deeply grateful to our researchers, collaborators, and the patients and families who participated in the Kymriah clinical program", added Bruno Strigini, CEO of Novartis Oncology.

This type of immunotherapy, known as a CAR-T cell therapy, was known by the term CTL019 until now. More than half were children and teens.

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The disease is the most common type of childhood cancer in the US, making up 25 percent of cancer diagnoses for children under 15 years old, according the National Cancer Institute.

"Kymriah is a first-of-its-kind treatment approach that fills an important unmet need for children and young adults with this serious disease", said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.

It's too soon to tell how widely applicable CAR-T will be - it's especially suited to leukemia since infusing patients with T-cells is relatively simple.

Novartis announced an agreement with the U.S. Centers for Medicare and Medicaid Services under which payment for the therapy will be based on clinical outcomes achieved.

Kymriah comes with a boxed warning for neurological events and cytokine release syndrome (CRS), which can both be life-threatening. The FDA also released a treatment for these side effects on Wednesday.

Novartis is required to conduct followup study to assess the safety of the treatment long-term.

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