Work

Leveraging National Cancer Institute Programmatic Collaboration for Single Radiopharmaceutical Drug Master Files

Year: 2019

Type: article

Abstract: Targeted radiopharmaceutical conjugates intended for therapeutic use often are made of three key components, a decaying radionuclide, a chemical chelator/linker, and a targeted molecular entity. The National Cancer Institute (NCI) Experimental Therapeutics Program has accepted four radiopharmaceutical drug products so far that fit the targeted radiopharmaceutical conjugate class. As the NCI sharpens its thinking about its role as an investigational new drug sponsor for radiopharmaceuticals in clinical development, it has considered the relative merits of modular radiopharmaceutical drug master files. Here, the NCI provides its perspective on modular radiopharmaceutical drug master files as it initiates a clinical development program for such agents and further organizes its radiopharmaceutical Small Business Innovation Research portfolio.

Source: Frontiers in Oncology

DOI: 10.3389/fonc.2019.00573

Authors: Charles A. Kunos, Jacek Capala, Susan Percy Ivy

Institutions: National Institutes of Health, National Cancer Institute

Language: English

Topic: Radiopharmaceutical Chemistry and Applications

Subfield: Radiology, Nuclear Medicine and Imaging

Field: Medicine

Domain: Health Sciences

Open Access status: gold

Estimated APC paid: $2,490

Funder: National Cancer Institute