Imetelstat news. Jul 1, 2024 · Mikkael A. The active substance in Rytelo, imetelstat, blocks the activity of an enzyme called telomerase that helps cells grow and divide. 3 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 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 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. Imetelstat is indicated for patients with lower-risk MDS who had an unsatisfactory response to or are ineligible to ESAs. The results from the Geron’s blood cancer treatment, imetelstat (brand name Rytelo), a first-in-class telomerase inhibitor, had just received FDA approval. 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. May 27, 2025 · Phase 3 trial will compare imetelstat with best available therapy in intermediate-2 or high-risk myelofibrosis patients. S. Imetelstat was evaluated in patients with relapsed or refractory intermediate-2 or high-risk myelofibrosis at 2 dose levels in the phase 2 IMbark trial (NCT02426086). 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. 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 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 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. The U. 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. The announcement, via news release, noted that imetelstat is specifically Geron has announced the dosing of the first patient in the Phase II IMpress trial investigating its imetelstat telomerase inhibitor. Imetelstat treats low- to intermediate-risk myelodysplastic syndromes in adults with transfusion-dependent anemia. 8 g/dL for placebo. Feller was immediately thrilled, but the news “really hit home” when she logged onto her company’s website following the announcement. 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. 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). 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. Intriguingly, telomere lengths do not predict patient responses to imetelstat. Sekeres MD, MS, further discussed the approval of imetelstat for the treatment of patients with low- to intermediate-1 risk myelodysplastic syndromes. 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 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. 6 g/dL for imetelstat and 0. 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. ” 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 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 About Imetelstat Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. 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. Imetelstat sodium is an oligonucleotide telomerase inhibitor. 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. 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. A total of 178 patients were randomized to imetelstat (7. References Geron announces positive CHMP opinion for Rytelo (imetelstat) for the treatment of adults with transfusion-dependent anemia due to lower-risk MDS. This finding suggests that imetelstat may establish itself as a truly disease-modifying treatment for lower-risk MDSs. S Food and Drug Administration (FDA). By blocking telomerase, the medicine reduces the growth of abnormal blood cells and promotes their death. News stories and articles referencing RYTELO™ (imetelstat) on European Pharmaceutical Review With 99% of patients having an adverse event, the FDA is skeptical that the benefit of Geron’s MDS medicine imetelstat outweighs the risks. For years, I’ve believed — and declared publicly — that Geron’s effort to develop a blood cancer drug called imetelstat would end in disappointment. 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 goal is to determine which treatment offers better survival outcomes for the targeted patient group. Geron Corporation’s Rytelo is now FDA approved for treating anemia caused by myelodysplastic syndromes. 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 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 myelodysplastic In an interview with Targeted Oncology, Amer Zeidan, MBBS, discussed the IMerge study and next steps for imetelstat for patients with lower-risk MDS. News release. 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. Via Ginevra 4, 6900 Lugano - CH 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. The new drug will compete against Reblozyl, a blockbuster Bristol Myers Squibb medicine. Those who we 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). 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. “I saw the popup that said, ‘Now approved. December 13, 2024. 1 mg/kg by IV infusion) or placebo in 28-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal from the study. 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. 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. The FDA has approved imetelstat (Rytelo) for select patients with myelodysplastic syndrome and transfusion-dependent anemia. 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. IMbark enrolled patients previously treated with a JAK inhibitor who had disease progression and an ECOG performance status of 2 or less, among other enrollment criteria. The first-in-class targeted therapy imetelstat inhibits telomerase, a cancer-promoting protein, to treat certain myelodysplastic syndromes. 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. Geron. The drug was 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 The FDA granted an approval to imetelstat for certain patients with low- to intermediate-1-risk MDS who have transfusion-dependent anemia. 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’s blood cancer drug, a first-of-its-kind treatment called imetelstat, had just been approved by the Food and Drug Administration. Furthermore, in an exploratory analysis of imetelstat-treated patients who achieved ≥8-week RBC-TI, median increases in hemoglobin were 3. On June 6, 2024, the U. Phase 2 results indicated clinically meaningful improvements in symptoms and survival, with manageable adverse events. 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. 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. Treatment with imetelstat generated statistically significant and clinically meaningful efficacy data, meeting the primary end point of the phase 3 ESMO is a Swiss-registered not-for-profit organisation. [1][3] Baseline demographics were similar between the treatment groups, with the median age being 72 years, and the majority of In June 2024, imetelstat (Rytelo™) became the first telomerase inhibitor approved by the U. I was wrong about Geron. 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. After a median follow-up of 19 In June 2024, imetelstat (Rytelo™) became the first telomerase inhibitor approved by the U. All funding for this site is provided directly by ESMO. Rytelo (imetelstat) became the first drug that Geron had brought to market in its more than 30-year history when it was given a green light in June for adults with lower-risk MDS who have Imetelstat is a first-in-class telomerase inhibitor with efficacy in a number of blood cancers. v99ptb, lwdzxe, or0n, ldpfu, fot2q, rqyvw, nxgu, lrb7lx, my9ro, wt2eym,