Difference between revisions of "Imetelstat (Rytelo)"
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<!-- # '''Abstract:''' Kebede Begna, Rebecca R. Laborde, Mrinal M Patnaik, Terra L Lasho, Darci Zblewski, Christy Finke, Lauren Schimek, Betsy R. LaPlant, Curtis A. Hanson, Monic J. Stuart, Animesh Pardanani. Imetelstat, a Telomerase Inhibitor, Induces Morphologic and Molecular Remissions In Myelofibrosis and Reversal Of Bone Marrow Fibrosis. Blood Nov 2013,122(21)662 [http://www.bloodjournal.org/content/122/21/662 link to original abstract] --> | <!-- # '''Abstract:''' Kebede Begna, Rebecca R. Laborde, Mrinal M Patnaik, Terra L Lasho, Darci Zblewski, Christy Finke, Lauren Schimek, Betsy R. LaPlant, Curtis A. Hanson, Monic J. Stuart, Animesh Pardanani. Imetelstat, a Telomerase Inhibitor, Induces Morphologic and Molecular Remissions In Myelofibrosis and Reversal Of Bone Marrow Fibrosis. Blood Nov 2013,122(21)662 [http://www.bloodjournal.org/content/122/21/662 link to original abstract] --> | ||
# '''CR107110:''' Tefferi A, Lasho TL, Begna KH, Patnaik MM, Zblewski DL, Finke CM, Laborde RR, Wassie E, Schimek L, Hanson CA, Gangat N, Wang X, Pardanani A. A Pilot Study of the Telomerase Inhibitor Imetelstat for Myelofibrosis. N Engl J Med. 2015 Sep 3;373(10):908-19. [https://doi.org/10.1056/NEJMoa1310523 link to original article] [https://pubmed.ncbi.nlm.nih.gov/26332545/ PubMed] [https://clinicaltrials.gov/study/NCT01731951 NCT01731951] | # '''CR107110:''' Tefferi A, Lasho TL, Begna KH, Patnaik MM, Zblewski DL, Finke CM, Laborde RR, Wassie E, Schimek L, Hanson CA, Gangat N, Wang X, Pardanani A. A Pilot Study of the Telomerase Inhibitor Imetelstat for Myelofibrosis. N Engl J Med. 2015 Sep 3;373(10):908-19. [https://doi.org/10.1056/NEJMoa1310523 link to original article] [https://pubmed.ncbi.nlm.nih.gov/26332545/ PubMed] [https://clinicaltrials.gov/study/NCT01731951 NCT01731951] | ||
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| + | ==History of changes in FDA indication== | ||
| + | *2024-06-06: Approved for adults with low- to intermediate-1 risk [[Myelodysplastic syndrome|myelodysplastic syndromes (MDS)]] with transfusion-dependent anemia requiring four or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs). ''(Based on IMerge)'' | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' GRN-163L | *'''Code name:''' GRN-163L | ||
| + | *'''Brand name:''' Rytelo | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
| Line 21: | Line 25: | ||
[[Category:Telomerase inhibitors]] | [[Category:Telomerase inhibitors]] | ||
| − | [[Category:Essential thrombocythemia medications | + | [[Category:Essential thrombocythemia medications]] |
| − | [[Category:Myelodysplastic syndrome medications | + | [[Category:Myelodysplastic syndrome medications]] |
| − | [[Category:Myelofibrosis medications | + | [[Category:Myelofibrosis medications]] |
| − | [[Category: | + | [[Category:FDA approved in 2024]] |
Latest revision as of 17:56, 9 June 2024
Mechanism of action
From NCI Drug Dictionary: The sodium salt of imetelstat, a synthetic lipid-conjugated, 13-mer oligonucleotide N3' P5'-thio-phosphoramidate with potential antineoplastic activity. Complementary to the template region of telomerase RNA (hTR), imetelstat acts as a competitive enzyme inhibitor that binds and blocks the active site of the enzyme (a "telomerase template antagonist"), a mechanism of action which differs from that for the antisense oligonucleotide-mediated inhibition of telomerase activity through telomerase mRNA binding. Inhibition of telomerase activity in tumor cells by imetelstat results in telomere shortening, which leads to cell cycle arrest or apoptosis. Link to company website
Preliminary data
Essential thrombocythemia
- CP14B015: Baerlocher GM, Oppliger Leibundgut E, Ottmann OG, Spitzer G, Odenike O, McDevitt MA, Röth A, Daskalakis M, Burington B, Stuart M, Snyder DS. Telomerase Inhibitor Imetelstat in Patients with Essential Thrombocythemia. N Engl J Med. 2015 Sep 3;373(10):920-8. link to original article PubMed NCT01243073
Myelodysplastic syndrome
- IMerge: Platzbecker U, Santini V, Fenaux P, Sekeres MA, Savona MR, Madanat YF, Díez-Campelo M, Valcárcel D, Illmer T, Jonášová A, Bělohlávková P, Sherman LJ, Berry T, Dougherty S, Shah S, Xia Q, Sun L, Wan Y, Huang F, Ikin A, Navada S, Feller F, Komrokji RS, Zeidan AM. Imetelstat in patients with lower-risk myelodysplastic syndromes who have relapsed or are refractory to erythropoiesis-stimulating agents (IMerge): a multinational, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Jan 20;403(10423):249-260. Epub 2023 Dec 1. Erratum in: Lancet. 2024 Jan 20;403(10423):248. link to original article PubMed NCT02598661
Myelofibrosis
- CR107110: Tefferi A, Lasho TL, Begna KH, Patnaik MM, Zblewski DL, Finke CM, Laborde RR, Wassie E, Schimek L, Hanson CA, Gangat N, Wang X, Pardanani A. A Pilot Study of the Telomerase Inhibitor Imetelstat for Myelofibrosis. N Engl J Med. 2015 Sep 3;373(10):908-19. link to original article PubMed NCT01731951
History of changes in FDA indication
- 2024-06-06: Approved for adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs). (Based on IMerge)
Also known as
- Code name: GRN-163L
- Brand name: Rytelo