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When will the next gene therapy treatment receive approval from the FDA?

In August 2017, the U.S. Food and Drug Administration approved the first gene therapy available in the United States. The therapy is trademarked as Kymriah and is indicated only for children and young adults with acute lymphoblastic leukemia. From the FDA's press release:

"Kymriah is a genetically-modified autologous T-cell immunotherapy. Each dose of Kymriah is a customized treatment created using an individual patient’s own T-cells, a type of white blood cell known as a lymphocyte. The patient’s T-cells 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."

Although the treatment currently carries the risk of serious side effects (a risk mitigated by the rheumatologic drug tocilizumab) it represents a first foray for gene therapies into the clinic, after years of research on many approaches to reprogram human cells in an effort to fight disease. Kymriah received several destinations that accelerated the approval process, including "breakthrough therapy" and "priority review."

When will the next gene therapy treatment receive approval from the FDA?

This question will resolve as positive when a credible news outlet or press release (from the FDA or from a pharmaceutical company) reports approval of a gene therapy product that can be verified, either through explicit designation in the report or from checking against the FDA's list of approved cellular and gene therapy products, as the second gene therapy available in the United States.

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