Guidance on Nonclinical Studies and Labeling for Oncology Therapeutic Radiopharmaceuticals

https://ntp.niehs.nih.gov/go/892763

In August 2019 FDA published “Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations.” This guidance provides recommendations for nonclinical studies for therapeutic radiopharmaceuticals for the treatment of cancer, and specifically describes instances where studies are not needed, potentially reducing animal use.

When there is experience with the radionuclide or the ligand components of the radiopharmaceutical being developed, the nonclinical program can be abbreviated as needed, and the first-in-human dose can be based on clinical data as appropriate.
In general, no toxicity studies are warranted before a first-in-human study when the radiopharmaceutical is a neat radionuclide.
In addition, no genetic or reproductive toxicity or carcinogenicity study with the pharmaceutical, in either radiolabeled or nonradiolabeled form, is warranted during drug development or for approval.

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ICCVAM Biennial Report 2018-2019