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A Randomized, Open-label, Active-controlled, Multicenter Phase 3 Study to Investigate the Efficacy and Safety of Roxadustat for Treatment of Anemia in Subjects Receiving Chemotherapy Treatment for Non-Myeloid Malignancies

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Trial Profile

A Randomized, Open-label, Active-controlled, Multicenter Phase 3 Study to Investigate the Efficacy and Safety of Roxadustat for Treatment of Anemia in Subjects Receiving Chemotherapy Treatment for Non-Myeloid Malignancies

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Nov 2024

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At a glance

  • Drugs Roxadustat (Primary) ; Recombinant erythropoietin
  • Indications Chemotherapy-induced anaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors FibroGen

Most Recent Events

  • 12 Nov 2024 According to a FibroGen media release, company expects approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China in early 2025. If approved, FibroGen will receive a $10 million milestone payment from AstraZeneca.
  • 26 Feb 2024 According to a FibroGen media release, company expect approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China in mid-2024. If approved, FibroGen will receive a $10M milestone payment from AstraZeneca.
  • 24 Oct 2023 Results (n=140) assessing the efficacy and safety of roxadustat for anemia in patients with non-myeloid malignancies receiving multi-cycle treatments of myelosuppressive chemotherapy presented at the 48th European Society for Medical Oncology Congress

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