Imetelstat News, Johnson & Johnson’s Janssen Biotech has ended a nearly four-year-old collaboration with Geron, which as a result is regaining rights to the blood cancer candidate imetelstat, the companies said In June 2024, imetelstat (Rytelo™) became the first telomerase inhibitor approved by the U. Based on the novel mechanism of action imetelstat may provide clinical benefit to pts with intermediate-2 or high-risk MF with refractory/relapsed disease after JAK inhibitor therapy. [1][3] Baseline demographics were similar between the treatment groups, with the median age being 72 years, and the majority of Geron Corporation announced that the US Food and Drug Administration (FDA) has accepted Geron’s New Drug Application (NDA) for imetelstat, a telomerase inhibitor, for patients with lower risk myelodysplastic syndromes (MDS). In June 2024, imetelstat (Rytelo™) became the first telomerase inhibitor approved by the U. The National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines in Oncology to recommend imetelstat (Rytelo) as a Category 1 and 2A treatment for patients with lower-risk myelodysplastic syndrome (MDS)–related symptomatic anemia, according to a news release published by the treatment developer, Geron Corporation. Feller was immediately thrilled, but the news “really hit home” when she logged onto her company’s website following the announcement. We now show that Imetelstat is a first-in-class, direct, and competitive inhibitor of telomerase enzymatic activity that selectively induces apoptosis of malignant clones and allows for recovery of erythropoiesis. S. The Institute for Clinical and Economic Review (ICER) conducted a systematic literature review and cost-effectiveness analysis to evaluate […] Members of the committee reviewed findings from the phase 2/3 IMerge trial assessing imetelstat in patients with transfusion-dependent anemia in myelodysplastic syndromes. All funding for this site is provided directly by ESMO. By blocking telomerase, the medicine reduces the growth of abnormal blood cells and promotes their death. The announcement, via news release, noted that imetelstat is specifically The FDA approved imetelstat (Rytelo; Geron), an oligonucleotide telomerase inhibitor, for some adults with low- to intermediate-1–risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia. The results from the The investigators concluded, “Imetelstat offers a novel mechanism of action with durable transfusion independence (approximately 1 year) and disease-modifying activity for heavily transfused patients with lower-risk myelodysplastic syndromes who are not responding to or are ineligible for erythropoiesis-stimulating agents. News release. The goal is to determine which treatment offers better survival outcomes for the targeted patient group. Geron. Efficacy was assessed in IMerge, a double-blind trial involving 178 patients with MDS who were assigned in a 2:1 ratio to receive either imetelstat or a placebo. The Oncologic Drug Advisory Committee of the FDA found that imetelstat has robust data supporting its use for transfusion-dependent anemia in patients with myelodysplastic syndromes. The FDA granted an approval to imetelstat for certain patients with low- to intermediate-1-risk MDS who have transfusion-dependent anemia. These risks and uncertainties, include, without limitation, risks and uncertainties related to: (a) whether Geron is successful in commercializing RYTELO (imetelstat) for the treatment of certain Geron (GERN) posts positive top-line data from the phase III IMerge study investigating its lead candidate, imetelstat for treating lower risk myelodysplastic syndromes. ” The first-in-class telomerase inhibitor imetelstat is poised to expand the myelofibrosis treatment armamentarium should it prove safe and effective in the newly initiated phase 3 IMpactMF trial. A pilot study of imetelstat therapy in MF demonstrated complete and partial remissions, including some molecular remissions (Tefferi et al, N Engl J Med2015). Via Ginevra 4, 6900 Lugano - CH An FDA advisory committee voted 12-2 that the benefits of the investigational therapy imetelstat outweigh the risks for the treatment of transfusion-dependent anemia in certain adults with In an interview with Targeted Oncology, Amer Zeidan, MBBS, discussed the IMerge study and next steps for imetelstat for patients with lower-risk MDS. A total of 178 patients were randomized to imetelstat (7. Richard Pazdur: On June 6, 2024, the Food and Drug Administration approved imetelstat (Rytelo, Geron Corporation), an oligonucleotide telomerase inhibitor, for adults with low- to intermediate-1 risk On June 6, 2024, the U. eu is to provide easy access to existing information about imetelstat , its basic workings, clinical potential and results from preclinical and clinical studies. On June 6, the FDA approved imetelstat (Rytelo), an oligonucleotide telomerase inhibitor, for adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia Initial findings from the IMpress trial indicate that imetelstat demonstrated minimal efficacy in higher-risk MDS and AML in patients for whom standard therapies failed. Imetelstat. Mar 11, 2025 · Our first-in-class telomerase inhibitor RYTELO™ (imetelstat) is approved in the United States and the European Union for the treatment of certain adult patients with lower-risk myelodysplastic Jul 1, 2024 · Mikkael A. Imetelstat Achieves Meaningful and Durable Transfusion Independence in High Transfusion–Burden Patients With Lower-Risk Myelodysplastic Syndromes in a Phase II Study The following represents disclosure information provided by authors of this manuscript. Geron’s blood cancer treatment, imetelstat (brand name Rytelo), a first-in-class telomerase inhibitor, had just received FDA approval. It will be interesting to see whether combining imetelstat with “rescue” treatments will weaken its anti-tumor effect or, hopefully, may further improve hematopoietic output in patients with lower-risk MDSs. With 99% of patients having an adverse event, the FDA is skeptical that the benefit of Geron’s MDS medicine imetelstat outweighs the risks. Food and Drug Administration approved imetelstat (Rytelo) for adults with low- to intermediate-risk myelodysplastic syndromes with transfusion-dependent anemia that requires at least four red blood cell units over eight weeks. Imetelstat is indicated for patients with lower-risk MDS who had an unsatisfactory response to or are ineligible to ESAs. “I saw the popup that said, ‘Now approved. The following is a message from the Director of the FDA Oncology Center of Excellence, Dr. For years, I’ve believed — and declared publicly — that Geron’s effort to develop a blood cancer drug called imetelstat would end in disappointment. On June 6, 2024, the Food and Drug Administration approved imetelstat (Rytelo, Geron Corporation), an oligonucleotide telomerase inhibitor, for adults with low- to intermediate-1 risk 2 days ago · The US regulator has cleared Rytelo (imetelstat) for adults with lower-risk MDS who have transfusion-dependent anaemia and have stopped responding to or cannot be treated with Jan 30, 2025 · Although not yet approved worldwide, here we spotlight the current data for imetelstat and where it may fit in the therapeutic landscape of LR-MDS. 1 Specifically, among those with ring sideroblast Imetelstat sustained red blood cell (RBC) transfusion independence in patients with RBC transfusion–dependent lower-risk myelodysplastic syndrome. The drug was This finding suggests that imetelstat may establish itself as a truly disease-modifying treatment for lower-risk MDSs. The competitive telomerase inhibitor imetelstat produced prolonged independence from red blood cell (RBC) transfusions in a considerable number of patients with lower-risk myelodysplastic syndromes (MDS) who were ineligible for, had relapsed on, or been refractory to erythropoiesis-stimulating agents (ESA), according to new phase III findings published in The Lancet. Imetelstat sodium is an oligonucleotide telomerase inhibitor. Imetelstat is a first-in-class telomerase inhibitor with efficacy in a number of blood cancers. 6 g/dL for imetelstat and 0. Food and Drug Administration has approved a first-in-class telomerase inhibitor for the treatment of myelodysplastic syndrome with transfusion-dependent anemia. Geron has announced the dosing of the first patient in the Phase II IMpress trial investigating its imetelstat telomerase inhibitor. News stories and articles referencing RYTELO™ (imetelstat) on European Pharmaceutical Review The FDA has approved imetelstat (Rytelo) for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia requiring at least 4 red blood cell units over 8 weeks who have not responded to, or have lost response to, or are ineligible for erythropoiesis-stimulating agents. About Imetelstat Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. I was wrong about Geron. S Food and Drug Administration (FDA). Treatment with imetelstat generated statistically significant and clinically meaningful efficacy data, meeting the primary end point of the phase 3 References Geron announces positive CHMP opinion for Rytelo (imetelstat) for the treatment of adults with transfusion-dependent anemia due to lower-risk MDS. The first-in-class targeted therapy imetelstat inhibits telomerase, a cancer-promoting protein, to treat certain myelodysplastic syndromes. 1 mg/kg by IV infusion) or placebo in 28-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal from the study. Phase 3 trial will compare imetelstat with best available therapy in intermediate-2 or high-risk myelofibrosis patients. Recent findings from The National Comprehensive Cancer Network (NCCN) has updated its clinical practice guidelines in oncology to now recommend imetelstat (Rytelo) as a Category 1 and 2A treatment for symptomatic anemia in patients with lower-risk myelodysplastic syndromes (MDS). The European Medicines Agency (EMA) has officially validated the Marketing Authorization Application (MAA) for imetelstat, a novel, first-in-class investigational telomerase inhibitor designed to treat transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes (MDS Participants ongoing on imetelstat sodium and considered to be benefiting from treatment per Investigator in the Phase 3 Study or Ventricular Repolarization Substudy, have the option to continue receiving imetelstat sodium in the Extension Phase. Sekeres MD, MS, further discussed the approval of imetelstat for the treatment of patients with low- to intermediate-1 risk myelodysplastic syndromes. Geron announces FDA approval of Rytelo™ (imetelstat), a first-in-class telomerase inhibitor, for the treatment of adult patients with lower-risk MDS with transfusion-dependent anemia. Imetelstat may provide a new treatment approach in patients with lower-risk myelodysplastic syndromes (MDS) who require regular transfusions to treat anemia but are refractory or relapsed to erythropoiesis-stimulating agents (ESAs), according to interim results of the phase III global IMerge study. This website is a private initiative. The FDA has approved imetelstat (Rytelo) for select patients with myelodysplastic syndrome and transfusion-dependent anemia. Geron’s blood cancer drug, a first-of-its-kind treatment called imetelstat, had just been approved by the Food and Drug Administration. Food and Drug Administration (FDA) approved imetelstat (Rytelo™), an oligonucleotide telomerase inhibitor, for adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks that has not responded to, has lost response to, or is ineligible for erythropoiesis ESMO is a Swiss-registered not-for-profit organisation. More than 30 years after it was first formed, Geron is on the cusp of bringing its first product to market, after imetelstat hit the mark in a phase 3 trial in patients with myelodysplastic Positive results were announced from the phase III IMerge trial evaluating the first-in-class telomerase inhibitor imetelstat in patients with lower-risk myelodysplastic syndromes (MDS) who are relaps Key Takeaways Imetelstat shows potential in improving survival and modifying disease biology in myelofibrosis patients refractory to JAK inhibitors. After a median follow-up of 19 If approved, how might imetelstat benefit patients with lower-risk MDS? Reducing transfusion dependence is a huge boon to patients who are requiring transfusions, as it improves QOL. Geron Announces Positive CHMP Opinion for RYTELO™ (imetelstat) for the Treatment of Adults with Transfusion-Dependent Anemia due to Lower-Risk MDS December 13, 2024 06:36 AM Eastern Standard Time The study tests two interventions: Imetelstat, an experimental drug administered intravenously every 21 days, and Best Available Therapy (BAT), a non-JAK-inhibitor treatment selected by investigators. Intriguingly, telomere lengths do not predict patient responses to imetelstat. All relationships are considered compensated unless otherwise noted. Imetelstat has demonstrated significant efficacy in addressing unmet medical needs among patients with red blood cell (RBC) transfusion-dependent, lower-risk myelodysplastic syndromes (LR-MDS) who do not respond to or are ineligible for erythropoiesis-stimulating agents (ESAs). Findings from the phase 2/3 IMerge trial support the new drug application for imetelstat in the treatment of patients with transfusion-dependent anemia in lower-risk myelodysplastic syndrome. Imetelstat is an investigational first-in-class telomerase inhibitor designed to block the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies. 2 million in RYTELO® net product revenue in Q3 2025 Completed enrollment in Phase 3 IMpactMF clinical trial evaluating imetelstat in relapsed/refractory myelofibrosis Strengthened leadership team with appointment of Chief Commercial Officer and additional key executives Announced one The U. 1 Treatments are designated as Category The purpose of imetelstat. Read more Imetelstat Injection (Rytelo) The U. eu only publishes content that is publicly available and from known sources. The active substance in Rytelo, imetelstat, blocks the activity of an enzyme called telomerase that helps cells grow and divide. Imetelstat treats low- to intermediate-risk myelodysplastic syndromes in adults with transfusion-dependent anemia. December 13, 2024. In June 2024, imetelstat (Rytelo) was approved for the treatment of adults with LR-MDS with RBC-TD anemia requiring ≥ 4 RBC units/8 weeks who have not responded to or have lost response to or are ineligible for ESAs in the US (Geron Corporation, 2024). Imetelstat (Rytelo; Geron Corporation) was approved by the FDA on June 6, 2024, as a treatment for transfusion-dependent anemia in patients with lower-risk MDS who have not responded to, lost response to, or are ineligible for ESAs. Imetelstat Show advanced filters news Phase III data for novel telomerase inhibitor released 5 December 2023 | By Catherine Eckford (European Pharmaceutical Review) Currently, imetelstat is being reviewed by the FDA and EMA for the treatment of transfusion-dependent anaemia in adults with lower risk MDS. Furthermore, in an exploratory analysis of imetelstat-treated patients who achieved ≥8-week RBC-TI, median increases in hemoglobin were 3. Shares up. A new drug application seeking the approval of imetelstat for use as a therapeutic option for transfusion-dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic . 8 g/dL for placebo. 2 days ago · Now, the influential ICER has poured cold water over the company's celebrations with a report that concludes that the evidence behind Rytelo "is not adequate to demonstrate net health benefits for Achieved $47. emlca8, ntctd, vrmph, vgrec, 68cva, fpzuzp, d48x, moa6, rgi5q, ynjpv,