Gilead Receives FDA Approval for Magrolimab Plus Azacitidine in Higher-Risk MDS

Gilead Sciences today announced that the FDA has approved magrolimab, an anti-CD47 monoclonal antibody, in combination with azacitidine for the treatment of adults with newly diagnosed higher-risk myelodysplastic syndromes (MDS). In the Phase 3 ENHANCE trial, magrolimab plus azacitidine demonstrated a statistically significant improvement in overall survival compared to azacitidine alone. This approval represents the first CD47-targeting therapy approved in oncology and provides a new treatment option for higher-risk MDS patients.