News | February 02, 2009

FDA Embraces SNM’s INDProcess for PET Biomarkers

February 2, 2009 - 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.”

SNM is an international scientific and medical organization dedicated to raising public awareness about what molecular imaging is and how it can help provide patients with the best health care possible. SNM members specialize in molecular imaging, a vital element of today’s medical practice that adds an additional dimension to diagnosis, changing the way common and devastating diseases are understood and treated.

For more information: www.snm.org

Related Content

PET/CT Changes Care for 59 Percent of Suspected Recurrent Prostate Cancer Cases
News | Prostate Cancer | June 13, 2018
A recently presented investigational clinical trial evaluated the impact of 18F fluciclovine positron emission...
News | Computed Tomography (CT) | May 21, 2018
The Istituto Oncologico Veneto (IOV) in Padua, Italy, has acquired MILabs’ latest-generation Versatile Emission...
PET Imaging Agent Could Provide Early Diagnosis of Rheumatoid Arthritis

Coronal 18F-FEDAC PET/CT section of a mouse with collagen-induced arthritis. (A) On day 23 and day 37, increased uptake is noted in the front and hind paws of this mouse with collagen-induced arthritis. (B) Predictive performance of day 23 18F-FEDAC uptake for the development of clinical arthritis. ROC = receiver operating characteristic; Sn = sensitivity; Sp = specificity. Credit: Seoul National University and Ewha Womans University, Seoul, South Korea

News | PET Imaging | May 17, 2018
A novel positron emission tomography (PET) tracer developed by Korean researchers can visualize joint inflammation and...
PET Imaging Shows Protein Clumping May Contribute to Heart Failure Development
News | PET Imaging | May 11, 2018
A team led by Johns Hopkins University Researchers has discovered that protein clumps appear to accumulate in the...
News | Radiopharmaceuticals and Tracers | May 09, 2018
Blue Earth Diagnostics signed an exclusive, worldwide agreement with Scintomics GmbH, Germany, a specialist in...
Novel PET Agent Could Help Guide Therapy for Brain Diseases

Rat brain 11C‐Me‐NB1 PET images (0‐60 min) superimposed on an MRI template. Credit: SD Krämer et al., ETH Zurich, Zurich, Switzerland

News | PET Imaging | April 10, 2018
Researchers have developed a new imaging agent that could help guide and assess treatments for people with various...
Imaging agent helps predict success of lung cancer therapy
News | Oncology Diagnostics | March 08, 2018
March 8, 2018 – Doctors contemplating the best therapy for...
Axumin PET Agent Added to NCCN Guidelines for Suspected Recurrent Prostate Cancer
News | PET Imaging | February 21, 2018
Blue Earth Diagnostics announced that Axumin (fluciclovine F 18) injection has been added to the National Comprehensive...
PSMA PET-CT Clearly Differentiates Prostate Cancer from Benign Tissue

68Ga-PSMA PET/CT images showing multifocal PCA in peripheral zone with GS of 5 1 5 5 10. (A and C) Axial PET images. (B and D) Fused PET/CT images. SUVmax of lesion in B was 84.3 and that of lesion in D was 5.7. IRS was 3, and 80% of cells were stained. Credit: Senior author V Prasad, Charité Universitätsmedizin Berlin, Berlin, Germany.

News | PET-CT | February 05, 2018
February 5, 2018 — Using nuclear medicine...
PET Tracer Measures Damage From Multiple Sclerosis in Mouse Models
News | PET Imaging | January 24, 2018
January 24, 2018 — The loss or damage of myelin, a cellular sheath that surrounds and insulates nerves, is the hallma
Overlay Init