Clinical Trials Arena March 15, 2024
The committee ultimately backed the benefits of imetelstat based on data from the Phase III IMerge clinical trial.
Advisers to the US Food and Drug Administration (FDA) on 14 March defended Geron‘s blood disorder drug, saying the benefits outweighed the risks associated with the treatment, based on data from a Phase III trial.
The FDA’s Oncologic Drugs Advisory Committee voted 12 to 2 in favour of the clinical benefit/risk profile of imetelstat based on results from the IMerge Phase III clinical trial (NCT02598661), to treat transfusion-dependent anaemia in patients with a group of blood cancers called myelodysplastic syndromes (MDS).
The Phase III IMerge trial enrolled 178 patients across North America, Europe, the Middle East, and Asia. Imetelstat, a...
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