Geron (NASDAQ:GERN) announced late Friday that the U.S. Food and Drug Administration (FDA) had approved its lead asset, imetelstat, as a late-line option for a type of blood cancer called myelodysplastic syndromes (MDS).
Accordingly, imetelstat, a telomerase inhibitor, will be available in the U.S. as Rytelo for adults with low- to intermediate-risk MDS who have developed anemia requiring blood transfusions.
The treatment will be indicated for those who have failed to respond or are ineligible to receive a class of medicines called erythropoiesis-stimulating agents.
With the approval, Geron (GERN) will compete against Bristol Myers (BMY) and Merck (MRK) which market Reblozyl, another MDS therapy approved for lower-risk patients.
The approval comes after an FDA advisory committee voted 12 to 2 in favor of imetelstat in March. The company has scheduled a conference call at 8 a.m. ET on Friday to discuss the regulatory win.