Posted by Michael Wonder on 20 Jun 2023
Geron announces submission of new drug application to FDA for first in class telomerase inhibitor imetelstat
20 June 2023 - Geron today announced the submission to the US FDA of a new drug application for imetelstat for the treatment of transfusion-dependent anaemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes who have failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents.
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.
