FDA finalises guidance on designing nonclinical studies and product labelling for radiopharmaceuticals used in oncology

The United States (US) Food and Drug Administration (FDA) have finalised their guidance on designing nonclinical studies and product labelling for radiopharmaceuticals used in oncology.

Recommendations in the guidance document can be applied to products that are administered systematically and undergo alpha, beta and/or gamma decay. The guidance is not applicable to therapeutic radiopharmaceuticals with a local route of administration, for example intrathecal or inhalation. The guidance discusses the following concepts: evaluation of toxicities from the ligand; evaluation of radiation toxicities and information for product labelling as related to reproductive toxicity, genotoxicity, carcinogenicity, contraception, and use in lactating women.

The FDA defines therapeutic radiopharmaceuticals for oncology as products which contain a radionuclide and are used in patients with cancer to treat the disease or palliate tumour-related symptoms, such as pain. The 16-page guidance aims to help sponsors design nonclinical studies ahead of first-in-human (FIH) trials and throughout pre-approval product development.

The FDA hopes that the guidance will provide a “more consistent approach in nonclinical studies and product labeling” for a “unique and challenging area of product development.”

To read the FDA’s final guidance on oncology therapeutic radiopharmaceuticals: nonclinical studies and labelling recommendations, please click here.