FDA approves SNM app for 18-FLT

The FDA has approved an SNM-sponsored centralized multi-center investigational new drug (IND) application for 18F-labeled 3'-deoxy-3'-fluorothymidine (FLT).

SNM said that FLT is an investigational PET imaging biomarker for demonstrating 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 to speed and simplify the drug development process.

The approval of chemistry manufacturing and controls in the FLT IND represents the demonstration of an FDA IND review process for PET imaging biomarkers. The agency has agreed to allow multiple sources of FLT to be evaluated, reviewed and accepted for use under a single IND. The FDA has also agreed to base the IND review process for acceptance of the various investigational FLT products on the end product specifications, the society said.

The 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, according to SNM.