Geron Reports the US FDA Acceptance of NDA for Imetelstat to Treat Transfusion-Dependent Anemia in patients with Lower Risk Myelodysplastic Syndromes
Shots:
- The US FDA has accepted the NDA of imetelstat (telomerase inhibitor) for transfusion-dependent anemia in patients with lower-risk MDS. The submission was based on the P-III trial (IMerge) evaluating imetelstat in a ratio (2:1) in 178 patients across North America, the EU, Middle East & Asia
- The 1EPs of 8wk. transfusion independence (TI) was higher with imetelstat with a median TI duration of 1yr. for imetelstat 8wk. TI responders, mean hemoglobin levels were increased over time & clinical efficacy results were achieved across key MDS subgroups irrespective of ring sideroblast status, baseline transfusion burden & IPSS risk category
- Improvement in fatigue was seen & the safety results were consistent with prior data. The company plans to submit an MAA in the EU in Q4’23
Ref: Businesswire | Image: Geron
Related News:- Janssen Terminates Development and Commercialization Agreement with Geron for Imetelstat
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