News: FDA un-pauses Bluebird Bio Gene Therapy trials

The FDA has lifted its temporary pause on bluebird bio’s gene therapy trials for adult, pediatric, and adolescent patients of sickle cell disease.


In February of this year, the FDA placed a hold on bluebird bio’s gene therapy trials of LentiGlobin for sickle cell disease (SCD). The pause came after two patients in the LentiGlobin trials developed blood cancer following their gene therapy treatment. Both patients experienced a suspected unexpected serious adverse reaction (SUSAR), one developing acute myeloid leukemia, and the other myelodysplastic syndrome.


Further review in March found that the AML SUSAR was “very unlikely” to have an association with the BB305 lentiviral vector. In April, additional analysis found that the MDS SUSAR had actually developed transfusion-dependent anemia, and a revised diagnosis was required.


The company is still in collaboration with trial investigators and sites to ensure a safe and effective restart to the studies.


The FDA has also lifted the hold in place on the company’s Phase III Northstar-2 and Northstar-3 trials of the related betibeglogene autotemcel gene therapy.


In a statement regarding the continuation of the studies, Andrew Obenshain of bluebird said: “we have gained deeper knowledge and understanding of the pathophysiology of sickle cell disease that will allow us to better serve patients and the broader community.”


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