GE: NCI submits investigational new drug application to the FDA

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GE Healthcare announced that the Cancer Imaging Program (CIP) of the National Cancer Institute (NCI) has submitted an investigational new drug (IND) application for 18F-Fluorothymidine (FLT) to the FDA. The IND submission is a product of a collaboration between GE and NCI under a clinical trials agreement.

FLT is a positron emission tomography (PET) agent that has shown promise as an in vivo means of providing important information about cellular proliferation that could improve cancer therapy response monitoring using PET imaging.

FLT is one of several promising PET tracers that have potential to expand the PET imaging tool kit beyond F-18 (Flouro-2-deoxy-D-glucose), which is currently the most widely used PET radiopharmaceutical available today. FLT's ability to detect changes in cellular proliferation or growth could complement FDG's ability to measure glucose metabolism, and may provide complementary biologic information that can be used by clinicians to improve cancer patient management, according to GE.   

The goal is to personalize cancer therapy by using several PET imaging agents to help oncologists select the most appropriate therapy and to reduce inappropriate treatments. It will be of critical importance in the future as more therapies become available, GE said.  

The multiyear effort cosponsored by NCI and GE involves the University of Washington, Johns Hopkins University, Virginia Commonwealth University Medical Center and Massachusetts General Hospital, all centers of excellence in PET imaging and tracer development. The collaborative program will expand to investigate the clinical utility of FLT for treatment monitoring of lung, breast and other cancers.  

"The results of these clinical trials may advance the state of the art in molecular imaging to support better clinical diagnosis, staging, and therapy follow-up in cancer care," said Alexander Tokman, general manager of Global Radiopharmacy and Molecular Imaging business at GE. "FLT application and its complementary properties to FDG in assessing and quantifying cell proliferation in tumors will be a valuable addition for the next generation multitracer synthesis platform being developed by GE."

The Phase I/II clinical trial that will initially be performed focuses on the clinical utility of FLT as a PET tracer in helping distinguish between radiation necrosis and tumor recurrence in patients with malignant brain tumors, GE said.