Comment from Saame Tina

I strongly support the FDA’s draft guidance aimed at reducing unnecessary animal testing in the development of oncology pharmaceuticals. The guidance represents an important step toward a more efficient, scientifically advanced, and patient-focused drug development paradigm by encouraging the use of New Approach Methodologies (NAMs) and other evidence-based approaches where appropriate. The FDA has stated that the draft guidance is intended to reduce unnecessary animal testing, streamline development, and lower the time and cost required to advance cancer therapies into clinical trials. From a cost-effectiveness perspective, NAMs have the potential to substantially reduce the resources required for preclinical development. Traditional animal studies, particularly long-term studies in non-human primates, are expensive, labour-intensive, and often require lengthy timelines. In contrast, human-cell-based assays, organoids, organ-on-chip systems, and computational models can frequently be conducted more rapidly and at lower cost while generating large amounts of mechanistic data. By reducing reliance on resource-intensive animal studies, sponsors may be able to allocate more funding toward innovation, clinical development, and the evaluation of promising therapies. The proposed approach may also accelerate the availability of new cancer treatments for patients. Cancer patients often face urgent unmet medical needs, making timely development of innovative therapies especially important. NAMs can generate relevant safety and biological information more quickly than conventional animal studies, reducing delays in decision-making and supporting a more agile development process. The FDA has recognised that streamlined approaches could reduce the time required to bring new cancer drugs into human trials, which is a significant public health benefit. Importantly, the advantages of NAMs extend beyond efficiency. Many NAMs are based on human-relevant biology and therefore have the potential to provide data that are more predictive of human responses than traditional animal models. Species differences in metabolism, immune function, target biology, and toxicity pathways can limit the translational value of animal studies. Advanced in vitro systems, human organoids, microphysiological systems, and in silico approaches can help address these limitations by generating data directly relevant to human physiology. The FDA has also noted that several validated NAMs have demonstrated stronger performance than traditional animal models in predicting human responses to drugs. I particularly support the draft guidance's risk-based, weight-of-evidence approach, which allows sponsors to integrate multiple sources of scientifically valid information, including NAM data, where appropriate. This flexible framework encourages innovation while maintaining rigorous standards for patient safety. Rather than applying a one-size-fits-all requirement for animal testing, the guidance appropriately focuses on obtaining the most informative and relevant safety data for each specific product. In conclusion, this draft guidance represents a forward-looking regulatory framework that can improve the efficiency, timeliness, and scientific relevance of oncology drug development. By facilitating greater use of validated NAMs and reducing unnecessary animal studies, the FDA can help accelerate patient access to innovative cancer therapies while supporting more reliable human-relevant safety assessments. I therefore strongly encourage the FDA to finalise and implement this guidance. Thank you for the opportunity to provide comments.