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

Click here ­to­ read full press release/ article | Ref: Gilead | Image: Biospace