A Phase 2, Multicenter, Single-Arm Bridging Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes(MDS) in Chinese and Japanese Subjects With Ring Sideroblasts Who Require Red Blood Cell Transfusions
Latest Information Update: 30 Sep 2024
At a glance
- Drugs Luspatercept (Primary)
- Indications Anaemia; Myelodysplastic syndromes
- Focus Registrational; Therapeutic Use
- Acronyms MEDALIST
- Sponsors Celgene Corporation
- 27 Jul 2023 According to a Bristol Myers Squibb media release, based on the MEDALIST and COMMANDS studies, the Japan's Ministry of Health, Labour and Welfare accepted the New Drug Application for Reblozyl as a treatment of anemia in adult patients with MDS.
- 01 May 2023 Status changed from recruiting to active, no longer recruiting.
- 20 May 2022 Planned primary completion date changed from 6 Oct 2023 to 26 Aug 2023.