Gilead's Magrolimab Receives the US FDA's Breakthrough Therapy Designation for Myelodysplastic Syndrome
Shots:
- The BT designation is based on part B of the P-I study assessing Magrolimab + Azacitidine in 33 previously untreated intermediate- high- and very high-risk MDS patients. The results are presented at the 2020 European Hematology Society Congress
- The part B of the P-I study showed positive results with 91% achieving OR and 42% achieving CR and the combination was generally well-tolerated
- Magrolimab is anti-CD47 mAb- currently being studied P-III ENHANCE trial in previously untreated higher MDS risk evaluating the safety and efficacy of dual regimen- as measured by CR and duration of CR. The therapy has received the US FDA’s FT designation for MDS- AML- DLBCL- and FL and the FDA’s ODD for MDS & AML along with EMA’s ODD for AML
Ref: Gilead | Image: Gilead
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