EMA's PRAC views safety of Zynteglo and updates on COVID-19 vaccines

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) held its July meeting this past week, and today reported on safety issues with a leukemia drug and four COVID-19 vaccines.

Firstly, the PRAC has concluded that there is no evidence that US biotech bluebird bio’s (Nasdaq: BLUE) Zynteglo (betibeglogene autotemcel), a gene therapy authorized to treat the rare blood condition beta thalassaemia, causes a blood cancer known as acute myeloid leukemia (AML).

The PRAC reviewed two cases of AML in patients treated with an investigational medicine, bb1111, in a clinical trial for sickle cell disease. Although there have been no reports of AML with Zynteglo, both medicines use the same viral vector and there was a concern that the vector may be implicated in the development of the cancer (insertional oncogenesis).