Darovasertib Medicine 03 June 2025 Extended indication Darovasertib in combination with crizotinib for first line treatment of metastatic HLA-A*02 negative uveal melanoma in adults and elderly. Therapeutic value No estimate possible yet Total cost € 11,562,000.00 Registration phase Clinical trials Product Active substance Darovasertib Domain Oncology Reason of inclusion New medicine (specialité) Main indication Oncology other Extended indication Darovasertib in combination with crizotinib for first line treatment of metastatic HLA-A*02 negative uveal melanoma in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Servier Portfolio holder Servier Mechanism of action Other, see general comments Route of administration Oral Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Werkingsmechanisme: proteïnekinase C theta + proteïnekinase C alfa inhibitor Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date September 2026 Expected Registration October 2027 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De trial is nog bezig, er zijn nog geen resultaten beschikbaar. Duration of treatment Frequency of administration Dosage per administration References NCT05987332 (DAR-UM-2) Additional remarks Expected patient volume per year Patient volume < 30 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR (1); Allelefrequencies.net (2) Additional remarks Er zijn 240 nieuwe gevallen oogmelanoom per jaar, waarvan stadium 2 (n=151), stadium 3 (n=36) en stadium 4 (n=0). De prevalentie is 930 patiënten. Tot 50% ontwikkelt over tijd stadium 4 over tijd, wat geschat wordt op maximaal 60 patiënten per jaar (1). Hiervan heeft 47% HLA-A* 02:01 (2). Ongeveer twee derde komt in aanmerking voor dit middel op basis van hoge medische noodzaak, geen alternatieven en een deel van patiënten die geen behandeling ontvangt. Expected cost per patient per year Cost € < 385,400.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Pakketadvies tebentafusp (Kimmtrak®) voor de behandeling van oogkanker. Zorginstituut Nederland. 2024. Additional remarks De kosten van dit middel zullen mogelijk gelijk zijn aan tebentafusp (Kimmtrak®). Hiervan bedragen de kosten per patiënt per jaar €385.361. Potential total cost per year Total cost € 11,562,000.00 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