FDA Drafts Guidance on Radiopharmaceuticals for Oncology

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As a means of assisting sponsors in designing appropriate nonclinical studies, FDA on Thursday released draft guidance on oncology therapeutic radiopharmaceuticals’ nonclinical studies and labeling.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

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In September 2017, FDA also released draft guidance on nonclinical study recommendations for microdose radiopharmaceutical diagnostic drugs.

To read the full text of the FDA guideline please visit:

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM612037.pdf 

To read the more please visit: https://www.raps.org/news-and-articles/news-articles/2018/6/fda-drafts-guidance-on-radiopharmaceuticals-for-on

Source: Regulator Affairs Professional Society