Gilead (NASDAQ: GILD) has announced that the US Food and Drug Administration (FDA) has imposed a partial hold on recruitment for a Phase III trial of its investigational anti-CD47 biologic, magrolimab, in acute myeloid leukemia (AML). The company has not disclosed the reason behind the FDA’s decision but has indicated that there is a possibility of resuming enrollment after further discussions with the regulatory agency.
Series of Setbacks for Magrolimab
This latest development follows a series of setbacks for the monoclonal antibody (mAb) magrolimab. Last year, the FDA temporarily paused its development in AML and myelodysplastic syndrome (MDS) due to safety concerns. Gilead subsequently abandoned its hopes for higher-risk MDS after the potential first-in-class immunotherapy failed to show efficacy in this indication.
Ongoing Clinical Development for Solid Tumors
Despite the challenges in the AML and MDS trials, Gilead has noted that the clinical development of magrolimab in solid tumors will not be affected. The drug is currently under evaluation in head and neck cancer, colorectal cancer (CRC), lung cancer, and breast cancer, in addition to its ongoing studies in AML, myeloid malignancies, lymphoma, and myeloma.-Fineline Info & Tech
