Imaging Agent for Onco-Nano Cancer Surgery Receives Breakthrough Therapy Device Designation
Pegsitacianine, an imaging agent that aids in the detection of malignancies in the peritoneal cavity after cytoreductive surgery, including ovarian cancer, has been given the Breakthrough Therapy designation by the FDA.
When not in use, pegsitacianine is fluorescently dark, but when acidic tumours are present, it quickly converts to a fluorescent "on" state.
Tumors that would normally go undetected can now be found with this imaging agent.
The Breakthrough Therapy program expedites the development and evaluation of medications for serious or life-threatening illnesses that show promising early clinical evidence in comparison to currently available therapies.
Pegsitacianine allowed surgeons to find more malignant tissue at a clinically significant rate of >50%, according to the findings of an ongoing Phase 2 clinical trial testing the safety and effectiveness of the drug after standard-of-care cytoreductive surgery.
Due to its distinct mode of action, pegsitacianine has the potential to serve as a tumor-indifferent imaging agent suitable for the majority of clinical cameras created for ICG imaging across a range of solid tumor types.
