WASHINGTON (dpa-AFX) - Geron Corp. (GERN) said that the U.S. Food and Drug
Administration has approved Rytelo (imetelstat) for the treatment of adult
patients with low- to intermediate-1 risk myelodysplastic syndromes or MDS with
transfusion-dependent or TD anemia requiring four or more red blood cell units
over eight weeks who have not responded to or have lost response to or are
ineligible for erythropoiesis-stimulating agents or ESA.

Lower-risk MDS is a progressive blood cancer with high unmet need, where many
patients with anemia become dependent on red blood cell transfusions, which can
be associated with clinical consequences and decreased quality of life.

The FDA approval of RYTELO was based on results from the IMerge Phase 3 clinical
trial. Durable and sustained red blood cell transfusion independence, increases
in hemoglobin levels and reduction in transfusion burden observed across key
LR-MDS subgroups in the IMerge Phase 3 clinical trial. The most common Grade 3/4
adverse reactions were thrombocytopenia and neutropenia, which were generally
manageable and short-lived.

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