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FDA embraces a new review process and approves SNM's multi-center IND for FLT

Reston, Va.SNM today announced FDA approval of an SNM-sponsored centralized multi-center investigational new drug (IND) application for 18F-labeled 3'-deoxy-3'-fluorothymidine (FLT).

The approval of multi-center Chemistry Manufacturing and Controls (CMC) in the FLT IND represents the successful demonstration of an important FDA IND review process for positron emission tomography (PET) imaging biomarkers. The FDA has agreed to allow multiple sources of FLT to be evaluated, reviewed and accepted for use under a single IND. FDA has also agreed to base the IND review process for acceptance of the various investigational FLT products on the end product specifications.

FLT is an investigational PET imaging biomarker that has apparent promise for demonstration of tumor proliferation. Therapeutics developers who have a desire to utilize FLT as a surrogate marker of effectiveness in the development of novel cancer therapies have been seeking access to a centralized, multi-center IND for FLT in order to speed and simplify the drug development process.

According to SNM President Robert W. Atcher, Ph.D., M.B.A., "Until now, FLT has been evaluated for investigational use under an IND at a limited number of imaging centers that have FDA-approved INDs in place. With the SNM's centralized IND now approved, multicenter investigational imaging is achievable in large (100+ center) therapeutic clinical trials through a single cross reference letter."

SNM's centralized, multi-center IND application was made possible, in part, through a letter of cross-reference to a master FLT IND held by the Cancer Imaging Program at the National Cancer Institute (NCI). NCI's IND was the result of significant work and investment by NCI and other collaborators toward their goal of making investigational radiopharmaceuticals available for drug development.

"We're aware that we don't have the resources needed to conduct large Phase 3 trials," said Jim Tatum, M.D., associate director of the division of cancer treatment and diagnosis at NCI. "Therefore, we strongly encourage imaging societies, academic institutions, cooperative groups and commercial sectors to work together to effectively lower this last barrier."

Over the past four years, NCI has allowed more than 20 entities to cross-reference this master IND. SNM combined the NCI information with information obtained from the University of Pennsylvania, Mayo Clinic, the University of Iowa, the University of Utah and the University of Washington. Most of these institutions hold a single site approved IND for FLT; however, each facility follows a different manufacturing process. The individual INDs describe end product FLT that is unique to each facility. Prior to the new centralized IND submission, FDA has not been asked to review these various production processes together or to base acceptance of the CMC on the end product formulation. Centralized, multi-center INDs are a key enabler for the recently formed SNM Clinical Trials Network, whose mission is to increase the use of imaging biomarkers in multi-center clinical trials.

"Since we received approval of SNM's centralized IND, several pharmaceutical developers have expressed interest in using FLT in near-term clinical trial multi-center work," said Atcher. "That's the real validation that this effort was worthwhile."


Contact: Amy Shaw
Society of Nuclear Medicine

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