{"entity":{"id":"cetuximab-sarotalocan","kind":"drug","name":"Cetuximab sarotalocan","aka":[],"tldr":"Cetuximab sarotalocan is an EGFR antibody carrying a light-activated dye: after infusion, a red laser is shone on the tumour and the cells burst. It has been approved in Japan since 2020.","summary":"Cetuximab sarotalocan is Rakuten Medical's photoimmunotherapy. It was approved in Japan (September 2020) for unresectable locally advanced or recurrent head and neck cancer with conditional approval; two global phase 3 trials in locally recurrent HNSCC continue without US approval to date. Also being studied in cutaneous squamous cell carcinoma.","status":"approved","asOf":"2026-09-07","links":[{"label":"Development status","url":"https://www.pharmaceutical-technology.com/data-insights/cetuximab-sarotalocan-rakuten-medical-recurrent-head-and-neck-squamous-cell-carcinoma-likelihood-of-approval/"}],"tags":[],"related":[],"cancers":["head-and-neck"],"sections":[],"technologies":["photoimmunotherapy"],"targets":["egfr"],"drugs":[],"companies":["rakuten-medical"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06699212"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Akalux","code":"ASP-1929, RM-1929","modality":"Photoimmunotherapy conjugate (anti-EGFR antibody-IR700 dye)","mechanism":"Cetuximab conjugated to IRDye700DX; 690 nm light triggers photochemical membrane damage in EGFR-bound cells and immunogenic cell death.","approvals":[{"region":"Japan","year":2020,"indication":"Unresectable locally advanced or recurrent head and neck cancer (conditional)"}],"mechanismSteps":["Antibody-dye conjugate binds EGFR on tumour cells within 24 hours","Near-infrared light (690 nm) is delivered by surface or interstitial fibres","Photochemical reaction ruptures the membrane of bound cells only","Released antigens and damage signals recruit an immune response"],"dosing":{"route":"Intravenous infusion, then light at 24 hours","schedule":"640 mg/m² followed by 50 J/cm² (surface) or 100 J/cm (interstitial) illumination; repeatable","source":"https://www.pmda.go.jp/english/"},"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2020-09-25","type":"approval","region":"Japan","note":"World-first approval of a photoimmunotherapy drug"}]},"route":"/drugs/cetuximab-sarotalocan/","neighbours":{"cancer":[{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"hpv-negative-head-and-neck-cancer","kind":"cancer","name":"HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer)","route":"/cancers/hpv-negative-head-and-neck-cancer/"},{"id":"recurrent-metastatic-hnscc","kind":"cancer","name":"Recurrent or metastatic head and neck squamous cell carcinoma","route":"/cancers/recurrent-metastatic-hnscc/"}],"technology":[{"id":"photodynamic-therapy-lasers","kind":"technology","name":"Photodynamic therapy lasers and light sources","route":"/technologies/photodynamic-therapy-lasers/"},{"id":"photoimmunotherapy","kind":"technology","name":"Photoimmunotherapy & photodynamic therapy","route":"/technologies/photoimmunotherapy/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"}],"company":[{"id":"rakuten-medical","kind":"company","name":"Rakuten Medical","route":"/companies/rakuten-medical/"}],"trial":[{"id":"nct06699212","kind":"trial","name":"A Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab in First-line Treatment of Locoregional Recurrent Squamous Cell Carcinoma of ","route":"/trials/nct06699212/"}],"idea":[{"id":"idea-photoimmunotherapy-plus-pd1","kind":"idea","name":"Photoimmunotherapy as an in situ vaccine with PD-1 blockade","route":"/ideas/idea-photoimmunotherapy-plus-pd1/"}],"roadmap":[{"id":"devices-roadmap","kind":"roadmap","name":"Devices and physical therapies roadmap: heat and light → electric fields and focused sound → drug-releasing implants","route":"/roadmaps/devices-roadmap/"}]}}