Matt Olszewski
Pictured: Corporate headquarters of Gilead in Silicon Valley/iStock, Sundry Photography
The FDA has put a partial clinical hold Gilead Sciences
The partial clinical hold applies to the initiation of new patients in U.S. studies examining magrolimab as a treatment for acute myeloid leukemia (AML), according to Gilead. It also applies to the expanded access program.
Patients who are already enrolled can continue to receive the therapy and be monitored per the current study protocol, the company said, while noting that their solid tumor program can continue without consequence.
Gilead said it is “working with regulatory authorities to determine next steps to release the partial clinical hold for new patient enrollment in the magrolimab AML studies” and that “global regulatory authorities and clinical trial investigators involved in the studies have been informed of the FDA’s decision.”
AML progresses rapidly without treatment and targets cells that are not fully developed, impairing their ability to perform normal functions. There is ongoing research in clinical trials to discover effective treatments for AML, and there are no known risk factors for the disease 29.8%.
Magrolimab, which Gilead gained in its 2020 $4.9 billion acquisition
The CD47 candidate has been in regulatory hot water before. An FDA hold lifted the block
The regulator’s latest hold comes a month after the company announced a discontinuation
Matt Olszewski is a freelance writer based in Boston. Reach him on LinkedIn
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