Navigation Links
FDA embraces a new review process and approves SNM's multi-center IND for FLT
Date:2/2/2009

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
ashaw@snm.org
703-652-6773
Society of Nuclear Medicine
Source:Eurekalert

Related medicine news :

1. Seabrook House Embraces the New Year with New Programs
2. Most inactive physicians retain licenses, return to practice without competency review
3. Statement on Presidential Memorandum to EPA to Review Lifting of Ban on California Clean Car Standard
4. VisionQwest Resource Group, Inc. Opens Nursing and English Review Centers in Asia
5. Stethoscope.com Website Now Offers Customer Product Reviews
6. China Pharma Holdings, Inc., Financial Year 2008 Preview
7. Review of Takedas Febuxostat New Drug Application Continues Past PDUFA Date
8. DrScore.com Says: Know Your Source When Going Online To Review Your Doctors Rating
9. Medarex Reviews Recent Highlights and Outlook for 2009
10. Johnson & Johnson to Review Fourth-Quarter and Full-Year 2008 Financial Results
11. Letting infants watch TV can do more harm than good says wide-ranging international review
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/24/2017)... (PRWEB) , ... March 24, 2017 , ... ... two panels at the Advanced ERISA Benefit Claims Litigation seminar in Chicago, Illinois. ... the Administrative Record, The majority of cases litigated under ERISA involve claims for ...
(Date:3/24/2017)... ... March 24, 2017 , ... Empower Brokerage, ... their training and leads programs. , In February, 2017, Empower Brokerage introduced their ... Performance Partners is designed to teach how to maximize their sales efforts, as ...
(Date:3/24/2017)... , ... March 24, 2017 , ... “Vintage and Harvest ... retired minister and college Bible teacher residing in North Carolina with his wife, Anna ... have blessed them with six grandchildren. David is also the author of “Shadow and ...
(Date:3/23/2017)... , ... March 23, 2017 , ... A recent report ... entry into teacher preparation programs. The NCTQ report suggests, based on a review of ... would significantly improve teacher quality in the U.S. It argues that this higher bar ...
(Date:3/23/2017)... ... 23, 2017 , ... PAINWeekEnd (PWE) Oklahoma City, on April ... will be an educational and exciting program providing busy clinicians and allied healthcare ... pain. , Oklahoma is in a healthcare crisis. The state ranks 46th in ...
Breaking Medicine News(10 mins):
(Date:3/23/2017)... -- Mosaic Life Care, based in St. Joseph, Missouri , has ... of 58 clinics, located in 22 cities, and its flagship St. Joseph Medical Center. ... the delivery of health care to its patients, including the insurance, billing and collections ... ... Mosaic Life Care St. Joseph Medical Center ...
(Date:3/23/2017)... Executive Summary ... primary research (inputs from industry experts, companies, stakeholders) ... the analysis of global heart valve devices market ... Replacement Procedure By Technique (Mechanical, Bioprosthetic, Transcatheter Aortic ... Balloon Valvuloplasty, Transcatheter Mitral Valve Repair (TMVR)), By ...
(Date:3/23/2017)... March 23, 2017 ... Healthcare disease pipeline guide Primary Hyperoxaluria - Pipeline ... Primary Hyperoxaluria (Genito Urinary System And Sex Hormones) ... condition characterized by recurrent kidney and bladder stones. ... called oxalate. Symptoms include blood in the urine, ...
Breaking Medicine Technology: