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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

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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: 15 Mar 2024

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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

    • Most Recent Events

    • 14 Mar 2024 According to a Geron Corporation media release, the FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 16, 2024 for Geron's New Drug Application (NDA) for imetelstat for the treatment of TD anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes, who have failed to respond, or have lost response to, or are ineligible for ESAs
    • 14 Mar 2024 According to a Geron Corporation media release, company announced that U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to 2 in favor of the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in adult patients with low-to-intermediate-1 risk myelodysplastic syndromes who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents based on the results of this trial.
    • 28 Feb 2024 According to a Geron Corporation media release, review of the imetelstat MAA for the same indication as the NDA expected to be completed in early 2025.Subject to approval by the European Commission, EU commercial launch of imetelstat could occur in 2025.
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