FDA Drafts Guidance on Radiopharmaceuticals for Oncology

As a means of assisting sponsors in designing appropriate nonclinical studies, FDA on Thursday released draft guidance on oncology therapeutic radiopharmaceuticals’ nonclinical studies and labeling.

The 17-page draft features sections on pharmacology, animal biodistribution and dosimetry, toxicology, first-in-human dose selection and labeling recommendations. FDA also defines a therapeutic radiopharmaceutical as a product that “contains a radionuclide and is used in patients with cancer for treatment of the disease or for palliation of tumor-related symptoms (e.g., pain).”

FDA explains how oncology therapeutic radiopharmaceuticals are generally administered intravenously and are intended to deliver cytotoxic levels of radiation to select tumor sites.

“Targeted delivery is generally achieved by the use of a targeting moiety, such as a peptide or an antibody,” the draft says. “Some radionuclides (known as organ seekers) are naturally directed to a particular organ, reaching a desired organ without a ligand. Examples include radium, which is a bone seeker, and iodine, which is a thyroid seeker.”

The guidance also discusses the following topics: Evaluation of toxicities from the ligand (e.g. an antibody previously evaluated for safety and efficacy in cancer treatment; Evaluation of radiation toxicities; Information for product labeling as related to reproductive toxicity, genotoxicity, carcinogenicity, contraception and use in lactating women.

In September 2017, FDA also released draft guidance on nonclinical study recommendations for microdose radiopharmaceutical diagnostic drugs.

Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Draft Guidance for Industry