The development of a blood cancer drug acquired by Gilead Sciences — the centerpiece of a $5 billion deal — has been interrupted by a potentially serious safety issue.
On Tuesday, the Food and Drug Administration placed a partial clinical hold on five clinical trials investigating the combination of the Gilead drug, called magrolimab, with another commonly used blood cancer medicine. The agency stepped in because of an “apparent imbalance in investigator-reported suspected unexpected serious adverse reactions” between study arms in one or more of the trials, Gilead said in a statement.
The company provided no clarifying information about the type of safety issue reported in the magrolimab studies, but said there was “no clear trend” and that the safety signal was not new.
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