The U.S. Food and Drug Administration has lifted a partial clinical hold on studies evaluating magrolimab in combination with azacitidine, Gilead Sciences Inc. said Monday.
said the FDA removed the partial clinical hold after reviewing comprehensive safety data from each trial. Following the FDA’s decision, enrollment in the U.S. can resume for studies investigating magrolimab in combination with azacitidine in myelodysplastic syndrome and acute myeloid leukemia.
During the partial clinical hold, patients already enrolled in the affected studies continued to receive treatment.
Gilead said myelodysplastic syndrome is a “rare, often unrecognized, under-diagnosed, bone marrow disorder widely considered to be a form of cancer.” Current estimates show about 100,000 new cases reported each year, according to Gilead.
About one in three with the condition will progress to Acute Myeloid Leukemia, the company said.
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