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.

“Gilead is working with regulatory authorities to determine next steps to release the partial clinical hold,” the company said in the press release.

The news marks the most recent setback for the drug, which came to Gilead in the $4.9 billion acquisition of Forty Seven in 2020. On July 21, the California drugmaker cited futility when it stopped its Phase III ENHANCE trial, which was testing magrolimab in combination with azacitidine in patients with higher-risk MDS.

Merdad Parsey

“We continue our efforts right now, hoping that magrolimab could have an effect in other diseases outside of MDS,” Gilead medical chief Merdad Parsey told investors in an earnings call on Aug. 3.

The FDA had also put the three Phase III trials testing magrolimab in high-risk MDS and AML on partial hold in January 2022, with the company reporting an “apparent imbalance” in investigator-reported SUSARs. That hold was lifted three months later.

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