Nivolumab Medicine 04 June 2024 Extended indication OPDIVO in combination with cisplatin-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Nivolumab Domain Oncology Reason of inclusion Indication extension IND Main indication Bladder cancer Extended indication OPDIVO in combination with cisplatin-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. Current proprietary name Already available biosimilars / generics Proprietary name Opdivo Manufacturer BMS Portfolio holder Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date August 2024 Expected Registration September 2025 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks NCT03036098 Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De resultaten van CHECKMATE 901 moeten worden afgewacht. Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2021 Additional remarks In 2021 waren er 754 patiënten met een stadium 3 en 459 patiënten met een stadium 4 carcinoom (1). Dit betekent dat er maximaal 1.213 patiënten in aanmerking zullen komen in de eerste lijn. 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 Unknown Indication extensions References Additional remarks Other information Additional remarks