Posted by Michael Wonder on 15 Sep 2020
Gilead’s magrolimab, an investigational anti-CD47 monoclonal antibody, receives FDA breakthrough therapy designation for treatment of myelodysplastic syndrome
15 September 2020 - On-going clinical program includes the Phase 3 ENHANCE trial in myelodysplastic syndrome.
Gilead Sciences today announced that the U.S. FDA has granted breakthrough therapy designation for magrolimab, a first-in-class, investigational anti-CD47 monoclonal antibody for the treatment of newly diagnosed myelodysplastic syndrome (MDS).
The FDA granted breakthrough therapy designation for magrolimab based on positive results of an ongoing Phase 1b study, which evaluated magrolimab in combination with azacitidine in previously untreated intermediate, high and very high-risk MDS.
