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The first telomerase inhibitor has been approved by the (imetelstat) is authorised for adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent (TD) anaemia.
The first-in-class oligonucleotide telomerase inhibitor is indicated for these patients who need four or more red blood cell units over eight weeks, who are unresponsive to or ineligible for erythropoiesis-stimulating agents (ESA).
"With the approval and availability of RYTELO, we believe eligible patients with lower-risk MDS can potentially experience meaningful clinical benefit, particularly the potential for greater than 24 weeks of freedom from the burden of red blood cell transfusions and symptomatic anaemia," stated Dr
[Trial results for RYTELO (imetelstat) demonstrate] the totality of the clinical benefit across LR-MDS patients irrespective of ring sideroblast status or high transfusion burden”
"What is exciting about RYTELO is the totality of the clinical benefit across LR-MDS patients irrespective of ring sideroblast status or high transfusion burden, including sustained and durable transfusion independence and increases in haemoglobin levels, all within a well-characterised safety profile of generally manageable cytopenias," commented Dr Rami Komrokji, Vice Chair,
Dr Komrokji remarked that the
Article: The promise of telomerase inhibitors for treating blood cancer
IMerge Phase III trial results
FDA based its decision on findings from the IMerge Phase III clinical trial for the telomerase inhibitor imetelstat, published in
The median RBC-TI duration for 8-week responders and 24-week responders treated with RYTELO was approximately one year and 1.5 years, respectively,
The company also highlighted that exploratory analysis showed RYTELO-treated patients achieved median increases in haemoglobin of 3.6 g/dL and 0.8 g/dL in individuals given placebo treatment.
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