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

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FDA has halted enrollment in clinical studies for Gilead Sciences’ magrolimab, a biologic treatment in development for acute myeloid leukemia.

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. However, patients who are already enrolled in AML clinical studies may continue to be treated and monitored, according to study protocol. Meanwhile, studies of magrolimab in solid tumors may continue and are not impactd by this FDA action.

Global regulatory authorities and clinical trial investigators involved in the studies have been informed of FDA’s decision. Gilead is working with regulatory authorities to determine the next steps needed to release the partial clinical hold.

Magrolimab is an investigational molecule that has not been approved anywhere globally, and Its safety and efficacy have not yet been established. In addition to AML, magrolimab is being developed as a potential treatment for myeloid malignancies, lymphoma, myeloma, head and neck cancer, colorectal cancer, lung cancer, and breast cancer.



1. Gilead Sciences, Gilead To Discontinue Phase 3 ENHANCE Study of Magrolimab Plus Azacitidine in Higher-Risk MDS. Press Release, July 21, 2023.

Source: Gilead Sciences