Gene Therapy And Secondary Malignancies: Integration Site Analysis Can Only Be Part Of The Answer

The US FDA seeks to better understand and predict insertional mutagenesis in gene therapies like bluebird bio's Skysona, which use integrating viral vectors, but a workshop on integration site analysis highlighted the approach's complexity and limitations.

Integrating viral vectors allow for persistent effects of gene therapies, but risk insertional mutagenesis. (Shutterstock)

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