OncoNano Gets Breakthough Therapy Nod for Cancer Surgery Imaging Agent

The FDA has granted Breakthrough Therapy status to OncoNano Medicine’s pegsitacianine, an imaging agent that helps identify tumors in the peritoneal cavity during cytoreductive surgery, including ovarian cancer.

Pegsitacianine is fluorescently dark when not in use but changes rapidly to a fluorescent “on” state in the presence of acidic tumors.

The imaging agent aids in detecting tumors that would otherwise be missed, the company said.

Southlake, Texas-based OncoNano Medicine is developing products to diagnose and treat cancer, including solid tumor therapeutics, agents for real-time image-guided surgery and T cell activating immunotherapies.

The Breakthrough Therapy program is designed to expedite the development and review of medicines that address a serious or life-threatening condition and show promising preliminary clinical evidence compared with available therapies.