Astellas’ Xospata (gilteritinib) Receives NMPA’s Conditional Approval for R/R AML with a FLT3 Mutation

February 4, 2021 Auto Bot approval, Astellas, NMPA, receives, regulatory 0

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

Click here ­to­ read full press release/ article | Ref: Astellas | Image: Behance

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