The US Food and Drug Administration (FDA) has placed a partial clinical hold on bringing new patients into studies evaluating magrolimab for the treatment of acute myeloid leukemia (AML), a condition that often arises from myelodysplastic syndromes (MDS), Gilead Sciences announced.
“Gilead is working with regulatory authorities to determine the next steps to release the partial clinical hold for new patient enrollment in the magrolimab AML studies,” company executives stated.
Effective immediately, researchers will have to discontinue the screening and enrollment of new study participants under the US investigational new drug application (IND 147229) and US Expanded Access Program.
Clinical trial investigators carrying out studies involving magrolimab and regulatory authorities across the globe have been informed about the FDA’s decision.
Read more about MDS experimental therapies
Patients with AML who have already been enrolled in studies will continue receiving the experimental medication and their overall health with be extensively monitored, according to the current study protocol.
Prior to the hold, the FDA announced a discontinuation of the phase 3 ENHANCE study of magrolimab in higher-risk MDS.
However, studies evaluating the use of magrolimab in solid tumors can proceed without any impact from this decision by the FDA.
Magrolimab, a potential first-in-class investigational anti-CD47 immunotherapy, blocks the inhibitory CD47-signal regulatory protein (SIRPα) interaction, giving macrophages and other phagocytes more capability to identify and destroy foreign and malignant cells.
The experimental drug is being developed as a potential treatment for AML, myeloid malignancies, lymphoma, myeloma, head and neck cancer, colorectal cancer, lung cancer, and breast cancer. It has not been approved anywhere in the world and its safety and efficacy are yet to be determined.
References
Gilead announces partial clinical hold for magrolimab studies in AML. News release. Gilead Sciences, Inc.; August 21, 2023.
