Cetuximab sarotalocan

Extended indication	Cetuximab sarotalocan monotherapy for third line or later treatment of locoregional, recurrent squamous cell carcinoma of head and neck in adults and elderly who are not eligible for curative treatment
Therapeutic value	No estimate possible yet
Registration phase	Clinical trials

Product

Active substance	Cetuximab sarotalocan
Domain	Oncology
Reason of inclusion	New medicine (specialité)
Main indication	Head and neck cancer
Extended indication	Cetuximab sarotalocan monotherapy for third line or later treatment of locoregional, recurrent squamous cell carcinoma of head and neck in adults and elderly who are not eligible for curative treatment
Manufacturer	Rakuten
Mechanism of action	Antibody-drug conjugate
Route of administration	Intravenous
Therapeutical formulation	Intravenous drip
Budgetting framework	Intermural (MSZ)

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	December 2024
Expected Registration	January 2026
Orphan drug	No
Registration phase	Clinical trials
Additional remarks	Indieningsdatum en verwachte registratie op basis van IHSI-inschatting.

Current treatment options	Cetuximab, methotrexate, of docetaxel
Therapeutic value	No estimate possible yet
Dosage per administration	640 mg/m²
References	NCT03769506 (ASP-1929-301)

References	NKR 2021 (1).
Additional remarks	In 2021 werden er 8.943 patiënten met plaveiselcelcarcinoom van de huid van hoofd en hals gediagnosticeerd, waarvan 149 stadium III en IV (1). Gezien dit een derdelijnsbehandeling is zal het verwachte patiëntvolume lager liggen.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.