Technology | November 20, 2013

Gallium-68 DOTATOC Receives FDA Orphan Drug Designation for NET Management

Radiopharmaceuticals and tracers nuclear molecular imaging pet systems SNMMI
November 20, 2013 — The Society of Nuclear Medicine and Molecular Imaging (SNMMI) announced that the U.S. Food and Drug Administration (FDA) has designated the radiopharmaceutical Gallium-68 (DOTA0-Phel-Tyr3) octreotide (Ga-68 DOTATOC) as an orphan drug for the management of neuroendocrine tumors (NET). This designation may lead to faster approval of the agent, which would greatly benefit NET patients in the United States. Currently, there are only a few small U.S.-based clinical trials for Ga-68 labeled NET positron emission tomography (PET) agents available for patients, who must otherwise travel out of the country if the scan is required to manage their disease.
 
In August 2013, SNMMI’s Clinical Trials Network (CTN) submitted an application to the FDA for orphan drug designation for Ga-68 DOTATOC under the Orphan Drug Act. This act provides for granting special status to a drug or biological product to treat a rare disease or condition. For a drug to qualify for orphan designation, the disease or condition must affect fewer than 200,000 people. With a prevalence of approximately 110,000 patients in the United States with NETs, Ga-68 DOTATOC meets this requirement.
 
With this new orphan drug designation, Ga-68 DOTATOC will be directed down a unique pathway within the FDA. On its road to approval, fewer patients will likely be required for clinical trials, and funds may be available for studies through the Office of Orphan Products Development (OOPD) grant program to support the clinical development of products where the proposed product will be superior to the existing product (Octreoscan). 
 
“The next step in this process will be to meet with FDA officials to discuss the data needed for regulatory approval, factoring in the extensive literature on the safety and efficacy of this agent and the patients currently enrolled in an ongoing prospective trial,” said Michael Graham, Ph.D., M.D. and co-chair, CTN.
 
SNMMI’s CTN will remain involved in the clinical trials for Ga-68-labeled DOTA agents as new studies begin. CTN has developed a comprehensive repository of materials to aid in the initiation and conduct of clinical trials including release criteria, an imaging manual, data collection forms and a template investigational new drug (IND) application for Ga-68 agents to help increase investigational use.
 
 “I think I speak for all NET patients when I say this is a great first step towards approval of this agent in the United States,” said Josh Mailman, chairman, SNMMI’s Patient Advocacy Advisory Board and president, NorCalCarciNET. “Ga-68-labeled NET PET radiopharmaceuticals will reduce the time it takes to image a NET patient from 2-3 days to just a few hours. It has also been shown in early studies in the U.S. and those overseas to change treatment paths for a number of patients. Lastly, the exposed dose of radiation is lower than the current standard of care. ”
 
For more information: www.snmmi.org

Related Content

ASNC and SNMMI Release Joint Document on Diagnosis, Treatment of Cardiac Sarcoidosis
News | Cardiac Imaging | August 18, 2017
August 18, 2017 — The American Society of Nuclear Cardiology (ASNC) has released a joint expert consensus document wi
Houston Methodist Hospital Enters Multi-Year Technology and Research Agreement With Siemens Healthineers
News | Imaging | August 17, 2017
Houston Methodist Hospital and Siemens Healthineers have entered into a multi-year agreement to bring cutting-edge...
Study Demonstrates First Human Application of Novel PET Tracer for Prostate Cancer

Transaxial 11Csarcosine hybrid PET/CT showed a (triangulated) adenocarcinoma in the transition zone of the anterior right prostate gland on PET (A), CT (B), and a separately obtained T2?weighted MR sequence (C) with resulting PET/MRI registration (D). Image courtesy of M. Piert et al., University of Michigan, Ann Arbor, Mich.

News | Radiopharmaceuticals and Tracers | August 16, 2017
In the featured translational article in the August issue of The Journal of Nuclear Medicine, researchers at the...
PET/CT Tracer Identifies Vulnerable Lesions in Non-Small Cell Lung Cancer Patients

Example of a patient with an upper left lung NSCLC: A: FDG; B: FDG PET/CT; C: Planning radiotherapy based on FDG (66Gy) with BTVm (GTV), CTV and PTV; D: PET FMISO E: FMISO PET/CT; F: boost based on the FMISO PET (76Gy) with BTVh (biological hypoxic target volume) and PTV boost. Credit: QuantIF – LITIS EA 4108 – FR CNRS 3638, Henri Becquerel Cancer Center, Rouen, France

News | PET-CT | July 14, 2017
July 14, 2017 — Fluorine-18 (18F)-fluoromisonidazole (FMISO) is a positron emission tomography (PET)...
Novel PET Tracer Detects Small Blood Clots

PET images (MIP 0-60 min) of three Cynomolgus monkeys. Strong signals are detected at the sites where inserted catheters had roughened surfaces. Almost no other background signal is visible. Only accumulation in the gallbladder becomes visible at the bottom of the image. Credit: Piramal Imaging GmbH, Berlin Germany.

News | PET Imaging | July 07, 2017
July 7, 2017 — Blood clots in veins a
Sponsored Content | Videos | Clinical Decision Support | June 29, 2017
Rami Doukky, M.D., system chair, Division of Cardiology, professor of medicine, Cook County Health and Hospitals Syst
Dual-Agent PET/MR With Time of Flight Detects More Cancer

Tc-99m MDP bone scan (left) is negative for osseous lesions. NaF/FDG PET/MRI (right and second slide) confirms absence of bone metastases, but shows liver metastases. Image courtesy of Stanford University.

News | PET-MRI | June 20, 2017
Simultaneous injections of the radiopharmaceuticals fluorine-18 fluorodeoxyglucose (18F-FDG) and 18F-sodium fluoride (...
Combined Optical and Molecular Imaging Could Guide Breast-Conserving Surgery

WLE specimen from a patient with a grade 3, ER-/HER2-, no special type (NST) carcinoma. (A) Cerenkov image; (B) Grey-scale photographic image overlaid with Cerenkov signal. An increased signal from the tumor is visible (white arrows); mean radiance is 871 ± 131 photons/s/cm2/sr, mean TBR is 3.22. Both surgeons measured the posterior margin (outlined in blue) as 2 mm (small arrow); a cavity shaving would have been performed if the image had been available intraoperatively. The medial margin (outlined in green) measured >5 mm by both surgeons. Pathology ink prevented assessing the lateral margin; a phosphorescent signal is visible (open arrows). (C) Specimen radiography image. The absence of one surgical clip to mark the anterior margin, and the odd position of the superior margin clip (white arrow) prevented reliable margin assessment. (D) Combined histopathology image from two adjacent pathology slides on which the posterior margin (bottom of image) and part of the primary tumor are visible (open arrows). The distance from the posterior margin measured 3 mm microscopically (double arrow). The medial margin is > 5 mm (not present in image). Credit: A. D. Purushotham, M.D., King’s College London, UK

News | Nuclear Imaging | June 20, 2017
June 20, 2017 — Breast-conserving surgery (BCS) is the primary treatment for early-stage...
Overlay Init