Geron Corporation (NASDAQ:GERN) disclosed Monday that it has received a Fast Track designation from the U.S. Food and Drug Administration (FDA) for Imetelstat for relapsed/refractory myelofibrosis.
The Menlo Park, Calif.-based firm says imetelstat is meant for the treatment of adult patients with Intermediate-2 or High-risk myelofibrosis (MF) whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment, or relapsed/refractory MF. The Fast Track designation includes patients with primary MF and MF developed after essential thrombocythemia or polycythemia vera.
There are currently no marketed drugs specifically approved for relapsed/refractory MF, representing a significant unmet medical need. Geron plans to conduct an End of Phase 2 meeting with the FDA by the end of the first quarter of 2020 to determine if there is a regulatory path forward for imetelstat in relapsed/refractory MF.
In all, some 13,000 patients are living with MF in the United States, with approximately 3,000 new cases diagnosed each year. There are currently only two drugs approved by the FDA for treating MF patients. The most widely used drug therapy for MF has a discontinuation rate of 75% after five years of treatment.
"Once patients discontinue treatment with this drug due to failure or lack of response," read Monday’s news release, "there are no specifically approved therapies, and the median overall survival for these MF patients is approximately 14 to 16 months."
Shares in GERN opened Tuesday up 15 cents, or 11.3%, to $1.48
