U.S. FDA cancels partial clinical suspension of Gilead's CD47 monoclonal antibody

Compilenewborn

Recently, Gilead announced that the U.

magrolimab, a monoclonal antibody that blocks CD47 signaling, was acquired after Gilead acquired Forty Seven in April 2020 for about $4.

Currently, magrolimab is being developed in several hematological and solid tumor malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML)

In January of this year, the FDA placed a partial clinical hold on multiple clinical studies of magrolimab in combination with azacitidine due to a significant imbalance in investigator-reported suspected unexpected serious adverse reactions (SUSARs) between treatment groups

Clinical studies evaluating magrolimab in combination with azacitidine for the treatment of MDS and AML will now resume patient enrollment in the United States, according to the latest decision issued by the FDA

Gilead is also collaborating with the FDA on the remaining clinical studies of magrolimab in diffuse large B-cell lymphoma (DLBCL) and multiple myeloma (MM) affected by a partial clinical hold

During the partial clinical pause, patients already enrolled in the affected clinical studies of magrolimab, including those in the pivotal Phase 3 ENHANCE study, continued to receive treatment

Reference source: FDA Lifts Partial Clinical Hold on MDS and AML Magrolimab Studies