Members of the FDA’s Oncologic Drugs Advisory Committee voted 12 to 2 on Thursday that the benefits of Geron’s imetelstat outweigh safety risks for the treatment of certain anemic myelodysplastic syndrome (MDS) patients who are dependent on blood transfusions.
While regulators raised concerns around cases of cytopenia, or low levels of white blood cells or platelets, advisory committee members said they were confident that the risks appear manageable. The FDA noted on Thursday that there was a “notably higher” incidence of neutropenia and thrombocytopenia in the imetelstat arm of a Phase III trial.
“Though I am concerned about the risks in this total trial population — in other words, not just the responders — I do believe it is more likely than not that there is a quality-of-life benefit here that is real,” University of Colorado associate professor Christopher Lieu said.
Stanford University School of Medicine professor Ranjana Advani added,…
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