The FDA placed a partial clinical hold on Gilead Science's phase 3 study of a potential therapy for acute myeloid leukemia, the Foster City, Calif.-based biopharmaceutical company said Aug. 21.
The trial, which is evaluating the efficacy and safety of monoclonal antibody magrolimab, cannot enroll new patients. Current patients in the study will continue to receive treatment and be monitored, and "studies of magrolimab in solid tumors [will] continue without any impact from the FDA action," Gilead said. The company did not state why enrollment is paused.
Magrolimab is not approved for any indication, and at least 32 studies are evaluating the antibody for different cancers, including myeloma, head and neck cancer, colorectal cancer, lung cancer, and breast cancer, according to clinicaltrials.com. The drug works to block the "don't eat me" signals from cancer cells, according to Gilead.
Results from the acute myeloid leukemia phase 3 trial have not yet been posted.
A month before announcing the FDA's hold, Gilead discontinued another phase 3 study of magrolimab, which was testing the drug plus azacitidine for higher-risk myelodysplastic syndromes.