Geron Corporation (Nasdaq: GERN) has announced that the National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines to include RYTELO™ (imetelstat) as a recommended treatment for symptomatic anemia in lower-risk myelodysplastic syndromes (MDS). The updated guidelines categorize RYTELO as a Category 1 and 2A treatment, reflecting a consensus of ≥85% among NCCN experts that this intervention is appropriate.
The NCCN Guidelines now specify that for lower-risk MDS patients without the del(5q) abnormality and symptomatic anemia, RYTELO is recommended based on ring sideroblast (RS) percentage and serum EPO levels. For RS- patients with symptomatic anemia:
- RYTELO is a Category 1 second-line treatment after erythropoiesis-stimulating agents (ESAs) or luspatercept for those with serum EPO ≤500 mU/mL.
- It is a Category 2A first-line treatment for those with serum EPO >500 mU/mL and unlikely to respond to immunosuppressive therapy.
For RS+ patients with symptomatic anemia:
- RYTELO is recommended as a Category 1 second-line treatment after luspatercept for those with serum EPO ≤500 mU/mL.
- It is a Category 2A first-line treatment for those with serum EPO >500 mU/mL.
“We believe this guideline update underscores the strength of RYTELO’s Phase 3 data and the U.S. Prescribing Information,” said Faye Feller, M.D., Geron’s Executive Vice President and Chief Medical Officer. “We hope this will increase awareness and adoption of RYTELO as a valuable treatment option for patients with lower-risk MDS.”
These updates follow the FDA’s June 2024 approval of RYTELO for adult patients with low- to intermediate-1 risk MDS and transfusion-dependent anemia who have not responded to or are ineligible for ESAs, and the publication of the IMerge Phase 3 trial data in The Lancet in December 2023.
About Lower-Risk Myelodysplastic Syndromes (LR-MDS)
Lower-risk MDS is a type of blood cancer that often leads to severe anemia and frequent red blood cell transfusions, which can significantly impact quality of life and survival. There is a significant unmet need for effective treatments that can help manage anemia and reduce dependence on transfusions.
About RYTELO™ (imetelstat)
RYTELO™ (imetelstat) is an FDA-approved telomerase inhibitor for treating adult patients with low- to intermediate-1 risk MDS and transfusion-dependent anemia who have not responded to or are ineligible for ESAs. It is administered intravenously every four weeks. RYTELO works by inhibiting telomerase activity, which is often overactive in MDS, allowing for uncontrolled cell division. Developed by Geron, RYTELO is the first and only telomerase inhibitor approved by the FDA.
Geron is committed to ensuring broad access to RYTELO through its REACH4RYTELO™ Patient Support Program, which offers resources to support access and affordability for eligible patients.
