Gilead Sciences announced that the US Food and Drug Administration (FDA) has placed a partial clinical hold on the initiation of new patients in US studies evaluating magrolimab to treat acute myeloid leukemia (AML).
The FDA action follows the previously announced discontinuation of the Phase 3 ENHANCE study of magrolimab in higher-risk myelodysplastic syndromes (HR-MDS).
Effective immediately, screening and enrollment of new study participants under the US investigational new drug application (IND 147229) and US 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 tumours continue without any impact from the FDA action.
Gilead informed that it 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.