Onfekafusp Alfa Medicine 03 June 2025 Extended indication Onfekafusp alfa in combination with doxorubicin for first line treatment of advanced unresectable and/or metastatic grade 2-3 Soft tissue sarcoma in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Onfekafusp Alfa Domain Oncology Reason of inclusion New medicine (specialité) Main indication Oncology other Extended indication Onfekafusp alfa in combination with doxorubicin for first line treatment of advanced unresectable and/or metastatic grade 2-3 Soft tissue sarcoma in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Philogen Portfolio holder Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Fibromun (L19TNF) or onfekafusp alfa is a fully-human immunomodulatory product consisting of the L19 antibody and TNF (a strong pro-inflammatory cytokine). The fusion of TNF to the L19 antibody specific to the EDB domain of fibronectin results in a tumor-targeted product, which selectively localizes at the site of disease, while sparing healthy organs. Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date March 2026 Expected Registration April 2027 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Verwachte indieningsdatum op basis van verwachte primary completion datum fase 3 studie. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De studie loopt nog. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 13µg/kg References NCT04650984 Additional remarks 13 µg/kg op dag 1, 3 en 5, elke 3 weken. Expected patient volume per year Patient volume < 339 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2022 (1) Additional remarks Volgens IKNL kwam een wekedelen sarcoom in 2022 bij 339 patiënten voor in stadium 2,3 en 4 (1). Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks