Gilead Reports the US FDA's Clinical Hold on Multiple Studies of Magrolimab + Azacitidine for Myelodysplastic Syndrome and Acute Myeloid Leukemia
Shots:
- The US FDA has issued a partial clinical hold in 5 clinical P-Ib, P-II & III (ENHANCE 1/2/3) studies evaluating the combination of magrolimab + azacitidine due to an apparent imbalance in investigator-reported SUSARs b/w study arms
- Additionally, no clear trend in the adverse reactions or new safety signal was observed while enrolled patients will continue to receive magrolimab, azacitidine, or PBO and closely monitored based on the current study protocol
- The company is working closely with regulatory authorities to determine the next steps to resolve the partial clinical hold for new patient enrollment for the affected studies
Ref: Gilead | Image: Gilead
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