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FDA Lifts Partial Clinical Hold On Gilead Sciences' MDS And AML Magrolimab Studies

Gilead Sciences, Inc. (GILD) on Monday announced that the U.S. Food and Drug Administration lifted the partial clinical hold placed on studies evaluating its investigational agent magrolimab in combination with azacitidine.

The FDA removed the partial clinical hold after a review of the comprehensive safety data from each trial.

Enrollment in the U.S. can resume for the studies investigating magrolimab in combination with azacitidine in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).

Gilead, in close coordination with regulatory authorities, is planning to re-open enrollment in the magrolimab studies that were placed on a voluntary hold outside of the U.S. The company is also working with the FDA regarding the remaining partial clinical hold affecting studies evaluating magrolimab in diffuse large B-cell lymphoma and multiple myeloma.

In January, FDA placed a partial clinical hold on studies evaluating the combination of magrolimab plus azacitidine due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions between study arms.

During the partial clinical hold, screening and enrollment of new study participants were paused in any study investigating the combination of magrolimab with azacitidine.

While, during the partial clinical hold, patients already enrolled in the affected Gilead magrolimab studies, including the pivotal, Phase 3 ENHANCE study, continued receiving treatment.

Magrolimab was granted Breakthrough Therapy designation for the treatment of newly diagnosed MDS by the FDA in 2020.

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