The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for imetelstat in the treatment of patients with lower-risk MDS.
Imetelstat, a telomerase inhibitor that targets transfusion-dependent anemia, significantly reduced red blood cell transfusion in patients enrolled in the IMerge phase 3 trial, according to a press release provided by Geron, the manufacturer of the therapy.
According to the EMA, imetelstat is indicated as monotherapy for the treatment of adult patients with transfusion-dependent anemia due to very low-, low- or intermediate-risk MDS without an isolated deletion 5q cytogenetic abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy Imetelstat will be available as 47 mg and 188 mg powder for concentrate for solution for infusion.
