Darleukin fibromun Medicine 08 December 2020 Extended indication Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C Melanoma Patients Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Darleukin fibromun Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Skin cancer Extended indication Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C Melanoma Patients Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Philogen Portfolio holder Mechanism of action Angiogenesis inhibitor Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2021 Expected Registration 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a week Dosage per administration References NCT03567889 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL data Additional remarks In 2016 waren er in totaal 419 patiënten in Nederland met een melanoom in stadium III. Gezien de indicatie geldt voor stadium IIIB en C, komt slechts een gedeelte van de patiëntpopulatie in aanmerking. 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References adisinsight Additional remarks Other information Additional remarks