{"entity":{"id":"radiopharma-roadmap","kind":"roadmap","name":"Radiopharmaceutical roadmap: iodine → lutetium → actinium","aka":[],"tldr":"The radiopharmaceutical roadmap runs eighty years from radioactive iodine for thyroid cancer to alpha-emitting drugs for prostate and neuroendocrine cancers, with isotope supply as the limiting factor.","summary":"The radiopharmaceutical roadmap runs from radioiodine curing differentiated thyroid cancer, the first theranostic, through radium-223 and Lutathera with its matched 68Ga-DOTATATE PET, to PSMA PET and Pluvicto building the first radioligand franchise. The current steps move Pluvicto and Lutathera into earlier lines amid an M&A wave, while the emerging step brings 225Ac and 212Pb alpha emitters and new targets such as FAP, GRPR, CAIX and B7-H3 into trials, with isotope supply as the limiting factor. The speculative end imagines radioligands as a standard modality with pan-cancer FAP theranostics and personalised dosimetry. The route links radioligand therapy, targeted alpha therapy, PSMA PET and FAPI PET, prostate, thyroid and neuroendocrine cancers, and the manufacturing bottleneck.","asOf":"2026-09-04","links":[{"label":"VISION: lutetium-177 PSMA-617 radioligand therapy extends survival in advanced prostate cancer (New England Journal of Medicine 2021)","url":"https://doi.org/10.1056/NEJMoa2107322"}],"tags":[],"related":["prostate-roadmap"],"cancers":[],"sections":["radiopharma"],"technologies":["radioligand-therapy","targeted-alpha-therapy","psma-pet","fapi-pet","radioimmunotherapy"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"steps":[{"era":"1946-2000","title":"Radioiodine and early radioimmunotherapy","description":"131I cures differentiated thyroid cancer, the first theranostic. Strontium-89 and samarium-153 palliate bone pain. 90Y-ibritumomab and 131I-tositumomab (2002-03) work in lymphoma but fail commercially.","refs":["thyroid"],"status":"historic"},{"era":"2013-2018","title":"Radium-223 and Lutathera","description":"Radium-223 (ALSYMPCA, 2013) is the first alpha emitter approved, for bone metastases. 177Lu-DOTATATE (NETTER-1, 2018) establishes the modern peptide receptor radionuclide therapy paradigm with a matched 68Ga-DOTATATE PET.","refs":["lutathera","sstr2"],"status":"historic"},{"era":"2020-2022","title":"PSMA theranostics","description":"PSMA PET approved (68Ga-PSMA-11 2020, Pylarify 2021); Pluvicto approved (VISION, 2022). Novartis builds the first radioligand commercial franchise; supply and site-capacity constraints appear.","refs":["psma-pet","pluvicto","vision","pylarify"],"status":"current"},{"era":"2023-2026","title":"Earlier lines, consolidation, and an M&A wave","description":"PSMAfore moves Pluvicto pre-chemotherapy (2025), NETTER-2 moves Lutathera to first line (2024); 2026 label expansions. BMS buys RayzeBio ($4.1B), AstraZeneca buys Fusion ($2.4B), Lilly buys Point; Bayer, Sanofi, Novartis expand. Pylarify TruVu approved March 2026. ITM-11 reads out a positive phase 3.","refs":["psmafore","ryz101","fusion-pharma","rayzebio","itm"],"status":"current"},{"era":"2026-2029","title":"Alpha emitters and new targets","description":"225Ac-PSMA (Novartis, Bayer Trillium, Fusion FPI-2265), 225Ac-DOTATATE (RYZ101) and 212Pb-DOTAMTATE are in phase 3; FAP radioligands (FAP-2286) are in phase 2; GRPR, CAIX, B7-H3, DLL3 radioconjugates are in early trials. TerraPower's Philadelphia Ac-225 plant aims for a 20-fold supply increase. Dosimetry-guided dosing enters trials.","refs":["ac225-psma","ryz101","fap-2286","terrapower-isotopes","orano-med","dosimetry"],"status":"emerging"},{"era":"2029+","title":"Speculative: radioligands as a standard modality","description":"Alpha therapy in hormone-sensitive prostate cancer and after ADC failure; pan-cancer FAP theranostics; radio-ADCs and pretargeting; combination with PARP inhibitors, IO, and ADCs; automated decentralised radiopharmacies; total-body PET for ultra-low-dose dosimetry.","refs":["radioimmunotherapy","beta-then-alpha","pet-ct"],"status":"speculative"}],"watch":[]},"route":"/roadmaps/radiopharma-roadmap/","neighbours":{"roadmap":[{"id":"hormonal-therapy-roadmap","kind":"roadmap","name":"Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test","route":"/roadmaps/hormonal-therapy-roadmap/"},{"id":"prostate-roadmap","kind":"roadmap","name":"Prostate cancer roadmap: from Huggins and the discovery that a cancer can depend on a hormone, through the PSA epidemic and what it cost, the androgen receptor drugs, the DNA repair subset and PSMA, to a 2032 registry watch","route":"/roadmaps/prostate-roadmap/"},{"id":"radiation-roadmap","kind":"roadmap","name":"Radiotherapy roadmap: X-rays → shaped beams → fewer fractions, particles and FLASH","route":"/roadmaps/radiation-roadmap/"}],"section":[{"id":"radiopharma","kind":"section","name":"Radiopharmaceuticals & Theranostics","route":"/fronts/radiopharma/"}],"technology":[{"id":"fapi-pet","kind":"technology","name":"FAPI PET","route":"/technologies/fapi-pet/"},{"id":"pet-ct","kind":"technology","name":"PET/CT","route":"/technologies/pet-ct/"},{"id":"psma-pet","kind":"technology","name":"PSMA PET","route":"/technologies/psma-pet/"},{"id":"radioimmunotherapy","kind":"technology","name":"Radio-antibody & radio-ADC","route":"/technologies/radioimmunotherapy/"},{"id":"radioligand-therapy","kind":"technology","name":"Radioligand therapy (beta emitters)","route":"/technologies/radioligand-therapy/"},{"id":"targeted-alpha-therapy","kind":"technology","name":"Targeted alpha therapy","route":"/technologies/targeted-alpha-therapy/"}],"cancer":[{"id":"neuroendocrine","kind":"cancer","name":"Neuroendocrine tumours","route":"/cancers/neuroendocrine/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"},{"id":"thyroid","kind":"cancer","name":"Thyroid cancer","route":"/cancers/thyroid/"}],"drug":[{"id":"ryz101","kind":"drug","name":"Actinium-225 DOTATATE","route":"/drugs/ryz101/"},{"id":"ac225-psma","kind":"drug","name":"Actinium-225 PSMA agents","route":"/drugs/ac225-psma/"},{"id":"fap-2286","kind":"drug","name":"FAP-2286 (177Lu / 68Ga)","route":"/drugs/fap-2286/"},{"id":"lutathera","kind":"drug","name":"Lutetium-177 dotatate","route":"/drugs/lutathera/"},{"id":"pluvicto","kind":"drug","name":"Lutetium-177 vipivotide tetraxetan","route":"/drugs/pluvicto/"},{"id":"pylarify","kind":"drug","name":"Piflufolastat F-18 / Pylarify TruVu","route":"/drugs/pylarify/"}],"target":[{"id":"sstr2","kind":"target","name":"Somatostatin receptor 2","route":"/targets/sstr2/"}],"trial":[{"id":"psmafore","kind":"trial","name":"PSMAfore","route":"/trials/psmafore/"},{"id":"vision","kind":"trial","name":"VISION","route":"/trials/vision/"}],"company":[{"id":"fusion-pharma","kind":"company","name":"Fusion Pharmaceuticals (AstraZeneca)","route":"/companies/fusion-pharma/"},{"id":"itm","kind":"company","name":"ITM Isotope Technologies Munich","route":"/companies/itm/"},{"id":"orano-med","kind":"company","name":"Orano Med","route":"/companies/orano-med/"},{"id":"rayzebio","kind":"company","name":"RayzeBio (BMS)","route":"/companies/rayzebio/"},{"id":"terrapower-isotopes","kind":"company","name":"TerraPower Isotopes","route":"/companies/terrapower-isotopes/"}],"term":[{"id":"dosimetry","kind":"term","name":"Dosimetry","route":"/terms/dosimetry/"}],"pairing":[{"id":"beta-then-alpha","kind":"pairing","name":"Beta radioligand → alpha radioligand","route":"/pairings/beta-then-alpha/"}],"bottleneck":[{"id":"b-manufacturing-cell-therapy","kind":"bottleneck","name":"Manufacturing cost and time for living and radioactive medicines","route":"/bottlenecks/b-manufacturing-cell-therapy/"}],"idea":[{"id":"idea-fund-academic-radiopharma-pipeline","kind":"idea","name":"A university cyclotron network with shared regulatory files for new tracers","route":"/ideas/idea-fund-academic-radiopharma-pipeline/"}]}}