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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