The FDA recently approved a new infused therapy, Rytelo (imetelstat) from Geron Corporation, for the treatment of adult patients with low – to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent (TD) anemia requiring four or more red blood cell units over eight 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 and is the first and only telomerase inhibitor approved by the FDA. It is indicated to be administered as an intravenous infusion over two hours every four weeks.
Rytelo is a first-in-class treatment that works by inhibiting telomerase enzymatic activity. Telomeres are protective caps at the end of chromosomes that naturally shorten each time a cell divides. In MDS, abnormal bone marrow cells often express an enzyme, telomerase, which rebuilds those telomeres, allowing for uncontrolled cell division.
The company has priced a single dose (47 mg) of Rytelo at $2,471.
Actual dosage is determined by patient weight.
Distribution will be supported by specialty pharmacies.
Onco360 has confirmed that it was named as a distribution partner.
CLICK HERE for prescribing information
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