FDA puts partial hold on Gilead’s CD47 hopeful in AML
The FDA put a partial clinical hold on Gilead’s magrolimab for acute myeloid leukemia, a month after the company scrapped late-stage development of the CD47 candidate in myelodysplastic syndromes.
Gilead said Monday morning it stopped screening and enrolling new patients in US trials studying the drug in AML, though patients already enrolled in the studies can continue treatment.
The partial hold affects two Phase III studies: ENHANCE-2, testing the drug with azacitidine in patients with untreated AML and TP53 mutations, and ENHANCE-3, which combines magrolimab with venetoclax and azacitidine for patients with AML who are ineligible for chemotherapy, a Gilead spokesperson told Endpoints News. Gilead’s expanded access program is also on pause.
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