Geron’s Rytelo (Imetelstat) Gains the US FDA’s Approval to Treat Myelodysplastic Syndromes (MDS) with Transfusion-Dependent Anemia
Shots:
- The US FDA has approved Rytelo to treat low- to intermediate-risk MDS with transfusion-dependent (TD) anemia adults who did not respond to, lost response, or are not eligible for erythropoiesis-stimulating agents (ESA)
- The approval was supported by the P-III (IMerge) study of Rytelo vs PBO, depicting a 39.8% vs 15.0% RBC-TI rate for 8wks. and 28.0% vs 3.3% for 24wks. RBC-TI was durable, with median durations of ~1yr. for 8wk. responders & 1.5yrs. for 24wk. responders
- The exploratory analysis showed 3.6 g/dL vs 0.8 g/dL median increase in hemoglobin among patients attaining ≥8wk. RBC-TI with meaningful efficacy in MDS subgroups, regardless of ring sideroblast status, baseline transfusion burden & IPSS risk category
Ref: Geron | Image: Geron
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