Geron Receives Fast Track Designation to Imetelstat for Myelofibrosis
More possible good news for upcoming therapies for myeloproliferative neoplasms. Geron was granted fast-track designation by FDA for imetelstat, which they have pursued in people with Intermediate-2 Myelofibrosis OR who have relapsed after or who are refractory to a JAK inhibitor such as Jakafi or Inrebic.
Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Early clinical data suggest imetelstat may have disease-modifying activity through the suppression of malignant progenitor cell clone proliferation, which allows potential recovery of normal hematopoiesis. Ongoing clinical studies of imetelstat consist of IMerge, a Phase 2/3 trial in lower-risk myelodysplastic syndromes (MDS), and IMbark, a Phase 2 trial in Intermediate-2 or High-risk myelofibrosis (MF). Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower-risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to Janus kinase (JAK) inhibitor treatment.