The Food and Drug Administration wants to shrink the role of animal testing in cancer drug development. A draft guidance issued this week outlines ways drugmakers can streamline nonclinical safety assessments, potentially shaving time off the journey from lab discovery to human trials.

Under the proposed framework, companies may be able to skip animal studies altogether when a biologic shows no binding or pharmacologic activity in animal species. In other cases, the guidance recommends using rodent-only studies instead of requiring both rodent and non-rodent species. It also suggests replacing three-month non-human primate studies with a weight-of-evidence risk assessment that could incorporate New Approach Methodologies, modern, non-animal methods the FDA recently formally recognized.

Angelo de Claro, who directs the FDA’s Oncology Center of Excellence, said the draft guidance “not only supports the FDA’s commitment to expedite regulatory pathways for meaningful treatments but also fulfills the agency’s promise to reduce the use of animal testing during drug development.”

The guidance builds on data analysis and practices developed during the COVID-19 pandemic to reduce non-human primate use. It supplements existing International Council for Harmonisation guidance and is part of the FDA’s broader effort to cut the roughly 10-to-12-year timeline for bringing new drugs from discovery to patients.

The agency is accepting public comments through July 30, 2026.

Source: FDA Press Release