Fast Track Designation Granted for Relapsed/Refractory Myelofibrosis Treatment

Officials from the FDA have granted Geron Corporation’s imetelstat fast track designation for adult patients with intermediate-2 or high-risk myelofibrosis (MF) whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment.

MF is a type of blood cancer in which abnormal of malignant precursor cells in the bone marrow multiply at a rapid rate, causing scar tissue to form, or fibrosis. People with MF may have an abnormal number of low or high red blood cells, white blood cells, or platelets in the blood or bone marrow. Fever, weight loss, night sweats, and itching are common debilitating symptoms in patients with MF.

Imetelstat is a first-in-class telomerase inhibitor exclusively owned by Geron. The injectable is being developed in hematologic myeloid malignancies.

The fast track designation includes patients with primary MF and MF developed after essential thrombocythemia or polycythemia vera. There are currently no marketed drugs approved specifically for relapsed/refractory MF.

Geron plans to conduct an End of Phase 2 meeting with the FDA by the end of the first quarter of 2020. This will determine if there is a regulatory path forward for imetelstat in relapsed/refractory MF.

The fast track designation decision is supported by results of IMbark, a Phase 2 clinical trial evaluating 2 starting dose levels of imetelstat. The coprimary efficacy endpoints for the trial are spleen response rate and symptom response rate.

Reference

Geron announces fast track designation granted to imetelstat for relapsed/refractory myelofibrosis [news release]. Menlo Park, CA; September 30, 2019: email. Accessed September 30, 2019.