USFDA places partial clinical hold on Magrolimab studies in acute myeloid leukemia: Gilead Sciences

The FDA action follows the previously announced discontinuation of the Phase 3 ENHANCE study of magrolimab in higher-risk myelodysplastic syndromes (HR-MDS).

Read also: Gilead to discontinue Phase 3 ENHANCE study of Magrolimab plus Azacitidine in higher-risk MDS

Effective immediately, screening and enrollment of new study participants under the U.S. investigational new drug application (IND 147229) and U.S. Expanded Access Program will be paused. Patients already enrolled in AML clinical studies may continue to receive treatment and be monitored, according to the current study protocol. Global regulatory authorities and clinical trial investigators involved in the studies have been informed of the FDA’s decision. Studies of magrolimab in solid tumors continue without any impact from the FDA action.

Gilead is working with regulatory authorities to determine next steps to release the partial clinical hold for new patient enrollment in the magrolimab AML studies.

Magrolimab is an investigational agent and has not been approved anywhere globally. Its safety and efficacy have not been established.

Magrolimab is a potential first-in-class investigational anti-CD47 immunotherapy. The primary mechanism of action of magrolimab is to block the inhibitory CD47-signal regulatory protein (SIRPα) interaction, enhancing the ability of macrophages and other phagocytes to identify and destroy foreign and malignant cells, with the goal of blocking the “don’t eat me” signal used by cancer cells. Magrolimab is being developed as a potential treatment for AML, myeloid malignancies, lymphoma, myeloma, head and neck cancer, colorectal cancer, lung cancer, and breast cancer.

Gilead Sciences is a biopharmaceutical company with headquarters in Foster City, California. The company operates in more than 35 countries worldwide, with headquarters in Foster City, California.