The FDA has issued a warning about a potential link between Bluebird Bio’s gene therapy Skysona and life-threatening blood cancers. Seven out of 67 children treated in clinical trials developed these cancers, prompting investigations and recommendations for alternative treatments where possible.
New data reveals that seven children treated with Bluebird Bio’s gene therapy for a severe neurological disorder have developed blood cancer. This raises concerns about the safety of the therapy, particularly given the FDA’s approval of the treatment despite previous reports of cancer cases. Researchers are monitoring the patients closely and expect more cancer cases in the coming years.
Bluebird Bio announced a restructuring plan aimed at optimizing costs and reaching quarterly cash flow break-even by the second half of 2025. The plan involves workforce reduction and a focus on the commercial launch of their gene therapies.
