FDA accepts GE molecular imaging agent for priority review

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The FDA has designated GE Healthcare’s AdreView, a molecular imaging agent for the detection of neuroendocrine tumors in pediatric and adult patients, for priority review for a new drug application (NDA).

The FDA also encouraged GE to establish an expanded access program for the agent to grant physicians limited access to a novel agent prior to FDA approval, according to the company.

“We believe this review designation reflects the appreciation of the potential importance of this agent for the diagnosis and management of these rare tumors. The expanded access program will provide immediate benefit to patients with these diseases, particularly children with neuroblastoma,” said Arnold Jacobson MD, PhD, GE’s clinical project leader for the AdreView program.

GE said it began development of AdreView (Iobenguane I 123 Injection) in 2004, and the agent was granted orphan-drug designation by the FDA in December of 2006. GE’s NDA for AdreView was submitted March 20, and accepted by the FDA May 20, the company said.