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FDA Lifts Hold on Studies of Cancer Drug Tosedostat
Agency requested data on heart-related events (January 2)
Cell Therapeutics, Inc. has announced that it has received notification from the FDA that the partial clinical hold on tosedostat (IND 075503) has been removed and that all studies underway may continue.
The FDA placed the hold after a patient treated with a combination of tosedostat and a chemotherapy drug died of a heart-muscle infection. The agency requested more information on all heart-related events in patients treated with tosedostat.
Tosedostat is a first-in-class selective inhibitor of aminopeptidases, which are required by tumor cells to provide amino acids necessary for growth and tumor cell survival. The drug is under development for the treatment of blood-related cancers. It is currently being studied in the U.S. and Europe in phase II trials in elderly patients with newly diagnosed and relapsed acute myeloid leukemia (AML) or with high-risk myelodysplastic syndrome (MDS).