FDA grants fast track status to investigational molecular imaging agent

The U.S. Food and Drug has granted Fast Track designation to an investigational imaging agent that has been shown to enhance complex abdominal and pelvic surgeries.

Tokyo-based Astellas Pharma received the FDA go-ahead on Wednesday which was handed down in order to expedite the development and review of its ASP5354 near-infrared fluorescence agent.

The tracer was developed to supplement surgeries and reduces the chance of iatrogenic ureteral injury (IUI) during colorectal or gynecologic procedures. IUI can lead to long-term complications such as acute or chronic renal failure or sepsis. And given that IUIs can require extensive reconstructive surgeries, managing these injuries can prove costly.

The FDA awarded the designation based on nonclinical and clinical data. The latter came in the form of a phase 1 study showing the agent was safe and well-tolerated in healthy volunteers. A phase 2 study is now underway testing the safety and efficacy of ASP5354 in patients undergoing colorectal surgery.