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Rytelo FDA Approval History

Last updated by Carmen Pope, BPharm on June 10, 2024.

FDA Approved: Yes (First approved June 6, 2024)
Brand name: Rytelo
Generic name: imetelstat
Dosage form: for Injection
Company: Geron Corporation
Treatment for: Myelodysplastic Syndrome

Rytelo (imetelstat) is an oligonucleotide telomerase inhibitor indicated for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion dependent anemia requiring 4 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 (ESA).

Development timeline for Rytelo

DateArticle
Jun  6, 2024Approval FDA Approves Rytelo (imetelstat) for the Treatment of Adult Patients with Lower-Risk MDS with Transfusion-Dependent Anemia
Mar 14, 2024Geron Announces FDA Oncologic Drugs Advisory Committee Votes in Favor of the Clinical Benefit/Risk Profile of Imetelstat for the Treatment of Transfusion-Dependent Anemia in Patients with Lower-Risk MDS
Aug 22, 2023Geron Announces PDUFA Date for Imetelstat NDA in Lower Risk MDS
Aug 21, 2023Geron Announces FDA Acceptance of New Drug Application for Imetelstat for the Treatment of Lower Risk MDS
Jun 20, 2023Geron Announces Submission of New Drug Application to FDA for First-in-Class Telomerase Inhibitor Imetelstat
Sep 30, 2019Geron Announces Fast Track Designation Granted to Imetelstat for Relapsed/Refractory Myelofibrosis
Oct 31, 2017Geron Announces Fast Track Designation Granted to Imetelstat for Lower Risk Myelodysplastic Syndromes

Further information

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