Nov 27 (Reuters) - The U.S. Food and Drug Administration
is weighing the need for a regulatory action on bluebird bio's
gene therapy for a rare neurological disorder, it said
on Wednesday, as the agency probes additional reports of blood
cancers from its use.
Skysona was approved by the FDA in 2022 for the treatment of
cerebral adrenoleukodystrophy.
The therapy's prescribing information included a warning for
blood cancers, including leukemia and myelodysplastic syndromes,
which are a group of cancers that occur when the bone marrow
produces immature blood cells instead of healthy ones.
The FDA said considering the risk of such cancers, patients
should consider alternative therapies.