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FDA Medication Tracker

← All approvals · Cancer · 2024

Rytelo (imetelstat)

The FDA approved Rytelo (imetelstat) on June 6, 2024 to treat low- to intermediate-1 risk myelodysplastic syndromes.
Brand name
Rytelo
Generic name
imetelstat
FDA approval date
June 6, 2024
Approved use (FDA wording)
To treat low- to intermediate-1 risk myelodysplastic syndromes
Company
Geron
Application
NDA217779
Dosage form / route
POWDER · INTRAVENOUS
Boxed warning on label
Not listed
Category on this site
Cancer

Indications and usage, from the FDA label

1. INDICATIONS AND USAGE RYTELO is 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). RYTELO 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 age…

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.