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

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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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