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Safety Thumbs Up For Zynteglo Prompts Bluebird To Lift Marketing Suspension

US Filing For The β-Thalassemia Gene Therapy Is On Track

 
• By Neena Brizmohun

No evidence has been found linking the viral vector in bluebird’s gene therapy for β-thalassemia to blood cancer, the European Medicines Agency says.

Gene therapy concept.
Zynteglo gene therapy is going back on the EU market • Source: Alamy

Bluebird bio is lifting its voluntary marketing suspension in the EU for its β-thalassemia gene therapy, Zynteglo (betibeglogene autotemcel), after the European Medicines Agency said its drug safety committee had found no evidence that the treatment can cause acute myeloid leukemia (AML).

The safety committee, the PRAC, started reviewing Zynteglo in February, after two cases of AML were found in patients who were being treated with bluebird’s investigational gene

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