Geron Receives Positive CHMP Opinion for Rytelo (Imetelstat) to Treat Transfusion-Dependent Anemia due to Lower-Risk MDS
Shots:
- The CHMP has recommended Rytelo to treat TD anemia in adults with very low, low, or intermediate risk non-del(5q) MDS, unresponsive or ineligible for erythropoietin-based therapy, with the EC’s decision expected in the coming months
- Opinion was based on P-III (IMerge) study of Rytelo vs PBO that showed reduced need for RBC transfusions within the first 24wks., with common side effects of thrombocytopenia, leukopenia, neutropenia, elevated liver enzymes (AST, ALT, ALP), asthenia & headache
- Rytelo is an oligonucleotide that inhibits uncontrolled cell division caused by over-expression of telomerase enzyme in LR-MDS; available as 47/188mg, IV infusion post approval
Ref: Geron | Image: Geron
Related News:- Geron’s Rytelo (Imetelstat) Gains the US FDA’s Approval to Treat Myelodysplastic Syndromes (MDS) with Transfusion-Dependent Anemia
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