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FDA Halts Clinical Trial Enrollment for Gilead’s Magrolimab in AML Studies

On Aug. 21, 2023, Gilead Sciences announced that FDA has placed a partial clinical hold on the company initiating new patients into US studies for magrolimab, an investigational anti-CD47 immunotherapy, to treat acute myeloid leukemia (AML). FDA’s decision follows a previous announcement in which a Phase III clinical study was discontinued that was studying magrolimab in higher-risk myelodysplastic syndromes (1).

According to a Gilead company press release, screening and enrollment of new study participants under US investigational new drug application (IND) 147229 and a US expanded access program will be paused, effective immediately.

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