Japan-based Astellas Pharma Inc. (TYO: 4503, OTCMKTS: ALPMY ) announced that the National Medical Products Administration (NMPA) has converted the conditional approval for its Xospata (gilteritinib) into regular approval. The decision is based on data from the COMMODORE study, a Phase III trial comparing gilteritinib to salvage chemotherapy in patients with relapsed or refractory (r/r) acute myeloid leukemia (AML) with FMS-like tyrosine kinase 3 (FLT3) mutations.
Drug Profile
Xospata, a FLT3 inhibitor, was developed through a collaboration between Astellas and Kotobuki Pharmaceutical Co., Ltd. Astellas holds exclusive global rights to the drug’s development, manufacturing, and commercialization. In China, gilteritinib was included in the third batch of clinically urgent overseas drugs in November 2020 and received conditional approval in January 2021.-Fineline Info & Tech
