Fusion heralds FDA tumor therapy clearance

The U.S. Food and Drug Administration (FDA) has cleared Fusion Pharmaceuticals' investigational new drug applications for two tumor therapy agents, actinium-225 FPI-2059 (FPI-2059) and the corresponding imaging analog indium-111 FPI-2058 (FPI-2058).

FPI-2059 is an alpha therapy designed to use a small molecule to target and deliver actinium-225 to tumor sites expressing neurotensin receptor 1, which is a protein that is overexpressed in multiple solid tumor cancers such as colorectal, pancreatic, gastric, neuroendocrine differentiated prostate, head and neck squamous cell carcinoma, and Ewing sarcoma.

Fusion plans to initiate a phase I clinical trial in patients with solid tumors expressing neurotensin receptor 1 that will focus on six solid tumor indications, it said.