Bluebird Bio’s LentiGlobin gene therapy is suspended following cancer reports

Bluebird bio announced the temporary suspension of its clinical studies of LentiGlobin gene therapy (autologous CD34+ cells encoding βA-T87Q-globin gene) for sickle cell disease (SCD) (bb111) after receiving reports of a suspected unexpected serious adverse reaction (SUSAR) of acute myeloid leukemia (AML). This is the second patient with SCD, also treated with LentiGlobin, to be diagnosed with AML in a short period of time. These reports are currently under investigation and no link to the LentiGlobin gene therapy has been yet established. Although no cases of hematologic malignancy have been reported in any patient treated with the LentiGlobin gene therapy for transfusion-dependent β-thalassaemia (licensed as ZYNTEGLO in the European Union and the United Kingdom), but since it is the same BB305 lentiviral vector used in the LentiGlobin gene therapy for SCD, the company also temporarily suspended marketing of its authorized gene therapy ZYNTEGLO while the AML case is assessed. More info: Bluebird bio press release