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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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
