Cetuximab sarotalocan
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.
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.
1.Antibody-dye conjugate binds EGFR on tumour cells within 24 hours
- 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: www.pmda.go.jp/english/. Doses are for orientation; the current label governs.
- Medicare
- Not covered (not FDA-approved)
Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request. Approved in Japan only.
- Commercial insurance
- unknown
Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request.
Sources: CMS Medicare Coverage Database (NCDs and LCDs). Not medical or financial advice; verify with your plan.
- Notes
- Japan-only licence (Akalux); not available in the UK.
Sources: NICE search: cetuximab sarotalocan. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Compare all products across the US, EU, UK, Japan, China and Australia →
- 25 Sept 2020ApprovalJapan
World-first approval of a photoimmunotherapy drug
Approvals
| Region | Year | Indication |
|---|---|---|
| Japan | 2020 | Unresectable locally advanced or recurrent head and neck cancer (conditional) |
Trials
topRecruiting now (live from ClinicalTrials.gov)
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Latest papers
topQuery for this drug: (TITLE:"Cetuximab sarotalocan" OR ABSTRACT:"Cetuximab sarotalocan" OR TITLE:"Akalux" OR ABSTRACT:"Akalux" OR TITLE:"ASP-1929" OR ABSTRACT:"ASP-1929" OR TITLE:"RM-1929" OR ABSTRACT:"RM-1929") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Cetuximab sarotalocan, not a curated reading list.