

S10 Ep40: FDA Approval Insights: Imetelstat in Lower-Risk MDS and Transfusion-Dependent Anemia
Jul 1, 2024
The FDA's recent approval of imetelstat for treating lower-risk myelodysplastic syndromes and transfusion-dependent anemia takes center stage. Insights from the Phase III EMERGE trial showcase its ability to significantly improve red blood cell transfusion independence. The discussion also highlights a 40% rate of transfusion independence and remarkable hemoglobin enhancements among patients. Additionally, safety and management strategies for this innovative treatment reveal exciting future research possibilities, paving the way for broader patient access.
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Imetelstat's Efficacy in Lower-Risk MDS
- Imetelstat achieved nearly 40% eight-week transfusion independence in lower-risk MDS patients vs 15% with placebo.
- About one-third had durable responses lasting up to a year, showing impressive efficacy.
Hemoglobin Rise Independent of Other Factors
- Hemoglobin improved by about 3 g/dL in patients achieving transfusion independence with imetelstat.
- This improvement was independent of platelet transfusions or myeloid growth factor use.
Managing Imetelstat Toxicities
- Manage imetelstat-related cytopenias with drug holidays, dose reductions, or growth factor support.
- Monitor blood counts closely and adjust treatment to mitigate toxicities effectively.