Posted by Michael Wonder on 21 Aug 2023
Geron announces FDA acceptance of new drug application for imetelstat for the treatment of lower risk MDS
21 August 2023 - Geron Corporation today announced that the US FDA has accepted the filing of Geron’s new drug application for imetelstat, its first-in-class telomerase inhibitor, for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes (MDS).
The new drug application submission is based on results from IMerge Phase 3, in which the primary endpoint of 8 week transfusion independence (TI) was significantly higher with imetelstat vs. placebo (p<0.001), with median TI duration approaching one year for imetelstat 8-week TI responders.
