Trial Profile
A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects with IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) that is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment
Status:
Active, no longer recruiting
Phase of Trial:
Phase II/III
Latest Information Update: 12 Mar 2025
Price :
$35
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At a glance
- Drugs Imetelstat (Primary)
- Indications Myelodysplastic syndromes
- Focus Registrational; Therapeutic Use
- Acronyms IMerge
- Sponsors Geron Corporation; Janssen Research & Development; Janssen-Cilag
- 11 Mar 2025 According to a Geron Corporation media release, company announced that the European Commission (EC) has granted marketing authorization for RYTELO (imetelstat) as a monotherapy for the treatment of adult patients with transfusion-dependent anemia due to very low, low or intermediate risk myelodysplastic syndromes. The marketing authorization of RYTELO approved by the EC is supported by data from the IMerge Phase 3 clinical trial.
- 13 Dec 2024 According to a Geron Corporation media release,Committee for Medicinal Products for Human Use(CHMP)of European Medicines Agency(EMA) has adopted a positive opinion recommending approval of RYTELO(imetelstat) for treatment of adult patients with transfusion-dependent anemia.The European Commission(EC),which has authority to approve medicines in European Union(EU),will review CHMP's recommendation and is expected to make a final decision on marketing authorization application(MAA)in coming months.
- 10 Dec 2024 According to a Geron Corporation media release, company announced new analyses presented at the 66th American Society of Hematology (ASH) Annual Meeting from the IMerge clinical trial in patients with lower-risk myelodysplastic syndromes