On March 14th, 2024, the FDA’s Oncologic Drugs Advisory Committee (ODAC) met to discuss a New Drug Application to treat patients with lower-risk myelodysplastic syndromes (MDS). The ODAC is an independent group of advisors that review and discuss new results available and share their recommendations with the FDA before they announce a decision. However, the recommendation does not determine the final FDA’s decision.
Imetelstat (Geron) is the first of a new type of therapy called telomerase inhibitors being tested to treat patients with low- to intermediate-risk MDS who have lost response to or are ineligible for treatment with erythropoietin-stimulating agents.
The IMerge trial enrolled transfusion-dependent patients with low-risk MDS who could not be treated with erythropoiesis-stimulating agents (ESAs, like Epogen) or had lost response to it. This study showed that after being treated with imetelstat, 39.8% of those patients became transfusion-independent for at least 8 consecutive weeks, and 28% did not need any transfusion for 6 months. However, more than 60% of patients treated with imetelstat also experienced a reduction of platelets and an increased risk of infections, which was resolved in most cases.
For more information about imetelstat and the IMerge clinical trial results, see our previous article, ‘The Promising Treatment Of Imetelstat And Transfusion Independence’.
The panel reviewed and discussed all the data available on imetelstat and concluded that the benefits of imetelstat are greater than its risks for the treatment of transfusion-dependant anemia in adult patients with low- to intermediate-1 risk MDS who cannot be treated anymore with erythropoiesis-stimulating agents.
The Committee was asked to review and discuss the available data around the following key points:
With 12 votes in favor and 2 votes against, the ODAC recommended the FDA approve imetelstat for the treatment of MDS patients.
The maker of imetelstat, Geron, announced that it expects a final decision from the FDA in June 2024 unless they ask for more data. In addition, imetelstat is also being reviewed for commercialization in Europe.
To learn more about MDS risk classification and treatment, visit HealthTree University for MDS, where you can find out if new treatments like luspatercept or imetelstat could help you.
Learn About MDS Treatments Here
On March 14th, 2024, the FDA’s Oncologic Drugs Advisory Committee (ODAC) met to discuss a New Drug Application to treat patients with lower-risk myelodysplastic syndromes (MDS). The ODAC is an independent group of advisors that review and discuss new results available and share their recommendations with the FDA before they announce a decision. However, the recommendation does not determine the final FDA’s decision.
Imetelstat (Geron) is the first of a new type of therapy called telomerase inhibitors being tested to treat patients with low- to intermediate-risk MDS who have lost response to or are ineligible for treatment with erythropoietin-stimulating agents.
The IMerge trial enrolled transfusion-dependent patients with low-risk MDS who could not be treated with erythropoiesis-stimulating agents (ESAs, like Epogen) or had lost response to it. This study showed that after being treated with imetelstat, 39.8% of those patients became transfusion-independent for at least 8 consecutive weeks, and 28% did not need any transfusion for 6 months. However, more than 60% of patients treated with imetelstat also experienced a reduction of platelets and an increased risk of infections, which was resolved in most cases.
For more information about imetelstat and the IMerge clinical trial results, see our previous article, ‘The Promising Treatment Of Imetelstat And Transfusion Independence’.
The panel reviewed and discussed all the data available on imetelstat and concluded that the benefits of imetelstat are greater than its risks for the treatment of transfusion-dependant anemia in adult patients with low- to intermediate-1 risk MDS who cannot be treated anymore with erythropoiesis-stimulating agents.
The Committee was asked to review and discuss the available data around the following key points:
With 12 votes in favor and 2 votes against, the ODAC recommended the FDA approve imetelstat for the treatment of MDS patients.
The maker of imetelstat, Geron, announced that it expects a final decision from the FDA in June 2024 unless they ask for more data. In addition, imetelstat is also being reviewed for commercialization in Europe.
To learn more about MDS risk classification and treatment, visit HealthTree University for MDS, where you can find out if new treatments like luspatercept or imetelstat could help you.
Learn About MDS Treatments Here
about the author
Marta Llobet Canela
Marta deeply believes that understanding how your body works is still a privilege today and that knowledge empowers. Leveraging her 9 years of experience in blood cancer, she translates complex medical jargon into easy-to-understand language, helping HealthTree’s mission to support patients staying informed about their disease and confidently participating in meaningful research. Outside of science, she enjoys trying new restaurants and hiking with her dog, Lia.
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