Grandbrothers/iStock Editorial via Getty Images 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.
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