Shots:

• The approval was based on P-III ADMIRAL assessing gilteritinib (120mg- qd) vs CT in 319 patients with relapsed or refractory AML. The study showed patients had significantly longer overall survival OS- mOS (9.3 vs 5.6mos.)
• Additionally- Chinese patient PK data from the ongoing P-III COMMODORE trial were also reviewed. The accelerated approval follows PR designation granted in Jul’2020 and its inclusion in overseas new drugs urgently needed in clinical settings
• Xospata is the 1st FLT3 inhibitor approved by the NMPA for patients with r/r AML

 ­ Ref: Astellas | Image: Astellas