Gilead Reports the US FDA’s Partial Clinical Hold on New Patient Enrolment of Magrolimab for Acute Myeloid Leukemia
- The US FDA has placed a partial clinical hold on the initiation of new patients into the US studies as well as for the expanded access program evaluating magrolimab, an anti-CD47 immunotherapy in patients with AML
- The decision was based on the previous announcement on the discontinuation of the P-III study (ENHANCE) for magrolimab + azacytidine in higher-risk myelodysplastic syndromes due to futility observed during a planned analysis. No new patients can be screened or enrolled at this time due to a partial clinical hold
- Enrolled patients may continue to receive treatment & monitored. The company is working with regulators to determine the next steps to release the hold and resume enrolment while studies of magrolimab in solid tumors continue without any impact action
Ref: Gilead | Image: Gilead
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