Metastasis prevention as a formal indication with its own trials and regulatory pathway
Metastasis causes most cancer deaths, yet no drug is developed to stop cells spreading. Create a formal approval route for drugs that prevent metastasis, tested in people at high risk of it.
Drug development targets established tumours; anti-metastatic mechanisms (blocking dissemination, colonisation or pre-metastatic niche formation) fail in trials designed to shrink measurable disease. The proposal is a recognised metastasis-prevention indication: trials in high-risk localised disease or MRD-positive patients with distant-recurrence-free survival as the endpoint, acceptance of mechanistically anti-metastatic agents without expectation of response in bulk disease, and biomarkers of dissemination (circulating tumour cells, ctDNA) as enrichment tools, developed with regulators.
- Metastasis is understood least and studied last · Metastasis causes about nine in ten cancer deaths but gets a small fraction of research money and almost no trials of its own.
- Trial design, endpoints and cost · A phase 3 trial takes years and hundreds of millions of dollars, and often answers a question that has already moved on.