ARTICLE | Product Development
Bluebird builds the case against gene therapy cancer link
But questions over how to assess integration risk re-emerge
March 11, 2021 12:14 AM UTC
Bluebird is seeking to resume clinical development and marketing of products based on the BB305 lentiviral vector after largely ruling it out as the cause of cancer in a clinical trial participant, but the case brings up lingering questions about the risks of lentiviral vectors.
Last month, FDA placed a clinical hold on a pair of studies evaluating LentiGlobin gene therapy (bb1111) for sickle cell disease and β thalassemia after bluebird bio Inc. (NASDAQ:BLUE) suspended the studies on the report of a suspected unexpected serious adverse event of acute myelogenous leukemia (AML). ...
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