{"entity":{"id":"idea-moon-metastasis-prevention-indication","kind":"idea","name":"Metastasis prevention as a formal indication with its own trials and regulatory pathway","aka":[],"tldr":"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.","summary":"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.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Metastasis is understood least and studied last): Dillekås et al., Are 90% of deaths from cancer caused by metastases? (Cancer Medicine 2019)","url":"https://doi.org/10.1002/cam4.2474"}],"tags":[],"related":[],"cancers":["colorectal","tnbc"],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant","mrd"],"trials":[],"people":[],"bottlenecks":["b-metastasis-biology","b-trial-design"],"keyPapers":["paper-dillekas-cancer-med"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Under the new pathway, at least two agents with anti-metastatic but not cytoreductive activity demonstrate reduced distant recurrence in randomised adjuvant trials within a decade.","rationale":"Adjuvant trials already accept recurrence endpoints; what is missing is a route for drugs whose only activity is anti-metastatic, and the biology of metastasis is now detailed enough to target.","test":"Regulatory guidance issued; first randomised MRD-enriched adjuvant trials of anti-metastatic agents in colorectal and breast cancer with distant recurrence as primary endpoint.","maturity":"speculative","actor":"regulator","cost":"large","horizonYears":8},"route":"/ideas/idea-moon-metastasis-prevention-indication/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"mrd-testing","kind":"technology","name":"MRD / molecular residual disease testing","route":"/technologies/mrd-testing/"}],"term":[{"id":"mrd","kind":"term","name":"Minimal / molecular residual disease (MRD)","route":"/terms/mrd/"},{"id":"neoadjuvant-adjuvant","kind":"term","name":"Neoadjuvant / adjuvant / perioperative","route":"/terms/neoadjuvant-adjuvant/"}],"bottleneck":[{"id":"b-metastasis-biology","kind":"bottleneck","name":"Metastasis is understood least and studied last","route":"/bottlenecks/b-metastasis-biology/"},{"id":"b-trial-design","kind":"bottleneck","name":"Trial design, endpoints and cost","route":"/bottlenecks/b-trial-design/"}],"paper":[{"id":"paper-dillekas-cancer-med","kind":"paper","name":"Are 90% of deaths from cancer caused by metastases?","route":"/key-papers/paper-dillekas-cancer-med/"}]}}