The FDA approved imetelstat for certain patients with relapsed or refractory low- to intermediate-risk myelodysplastic syndromes (MDS). This first-in-class telomerase inhibitor is for adults with MDS who have transfusion-dependent anemia and have not responded to other treatments. The approval was based on a phase 3 trial showing improved red blood cell transfusion independence with treatment. Adverse reactions included decreased platelets and white blood cells, as well as fatigue and headache. The recommended dose is 7.1 mg/kg every 28 days. Overall, imetelstat showed sustained and durable transfusion independence and increased hemoglobin levels with manageable side effects. This approval represents a significant advancement for patients with this condition.
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FDA Approves Imetelstat for Rare Low-Risk Blood Cancer
