GE Healthcare Gets Priority Review for Molecular Imaging Agent
The FDA has accepted for priority review GE Healthcare’s NDA for imaging agent AdreView. The product’s action date is Sept. 20.
AdreView, which received orphan status in 2006, is a molecular imaging agent designed to help detect neuroendocrine tumors in children and adults.
Although GE Healthcare said it was difficult to estimate the number of U.S. patients with pheochromocytoma and neuroblastoma, it estimated there are 20,000–30,000 people with pheochromocytoma and 5,000 children with neuroblastoma. About 3,000 new diagnoses of pheochromocytoma occur annually, along with 650 neuroblastomas.
According to Cedars-Sinai Medical Center in Los Angeles, neuroendocrine tumors are rare and often misdiagnosed. Symptoms vary widely, and diagnosis is frequently determined only after the cancer has spread to other parts of the body. Advanced imaging and laboratory technology is used to identify such tumors in their earliest stages, the medical center said.
While granting the AdreView NDA priority review, the FDA encouraged GE Healthcare to institute an expanded access program for the product. The company said it expects a response from the FDA by July 9, if not sooner, on the protocol submitted for the program. The firm does not intend to charge patients for the drug.