[18F]FAPI-74 diagnostic is available via single patient expanded access
SOFIE’s vision is to improve patient outcomes by developing and delivering molecular diagnostics and therapeutics (theranostics). With its robust radiopharmaceutical production and distribution network, mature contract manufacturing services, and development of tumor microenvironment targeting products, SOFIE is poised to deliver on the promise of radiopharmaceuticals.
SOFIE Co. dba SOFIE supports the need for Expanded Access to investigational drugs for patients. This policy applies to both adult and pediatric patients. All requests involving pediatric patients must include appropriate parenteral or legal guardian permission, and when applicable, assent from the pediatric patient.
Criteria:
• Patient has a serious or immediately life-threatening disease or condition.
• There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
• Patient enrollment in a clinical trial is not possible.
• Potential patient benefit justifies the potential risks of treatment.
• Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.