FDA Stops Bluebird Bio’s Sickle Cell Study After Serious Side Effects
The FDA has instructed Bluebird Bio to halt its gene therapy trial targeting sickle cell disease (SCD) after its candidate LentiGlobin caused suspected serious adverse reactions (SUSARs) during clinical trials.
This agency’s decision came after trials were stopped temporarily when a trial subject developed acute myeloid leukemia (AML) five years after being treated with LentiGlobin. Additionally, researchers are looking into whether an additional SUSAR of myelodysplastic syndrome is also linked to LentiGlobin.
The company also announced that it had temporarily stopped all sales of its approved gene therapy Zynteglo, a treatment for the blood disorder beta thalassemia. Zynteglo hasn’t had any reported adverse reactions, however it’s made with the same lentiviral vector as LentiGlobin.