PETNet Solutions, a subsidiary of Siemens Healthcare in Malvern, PA, has been tapped to supply the investigational fluorine-18 fluorothymidine (F-18 FLT) radiotracer to the SNM's Clinical Trials Network.
PETNet also is supplying the National Cancer Institute (NCI) with FLT through a previous filing of a cross-reference letter to the same type II drug master file that Siemens submitted to the U.S. Food and Drug Administration (FDA) for FLT.
The cross reference allows F-18 FLT to be produced and used by any principle investigator in an NCI or SNM multicenter clinical trial.
The imaging biomarker also will be available to investigators outside of NCI and SNM trials, if they receive independent FDA investigational new drug approval or other appropriate approval.
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