Posted by Michael Wonder on 01 Nov 2017
Geron announces fast track designation granted to imetelstat for lower risk myelodysplastic syndromes
31 October 2017 - Expanded part 1 of IMerge is open for patient enrolment.
Geron Corporation today announced that the US FDA has granted fast track designation to imetelstat for the potential treatment of adult patients with transfusion-dependent anaemia due to low or Intermediate-1 risk myelodysplastic syndromes who are non-del(5q) and who are refractory or resistant to treatment with an erythropoiesis stimulating agent.
Imetelstat is a telomerase inhibitor initially developed by Geron and exclusively licensed to Janssen Biotech on a worldwide basis. Janssen sponsored the application for fast track designation utilising preliminary data from IMerge, the ongoing clinical trial being conducted by Janssen in lower risk MDS.
