Fusion heralds FDA tumor therapy clearance

2022 06 24 17 22 8341 Carcinoid Neuroendocrine Tumor 400

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.

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