Oportuzumab monatox Medicine 12 June 2019 Extended indication Non Muscle-Invasive Carcinoma in Situ and/or High-Grade Papillary Disease of the Bladder Treated With BCG Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Oportuzumab monatox Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Bladder cancer Extended indication Non Muscle-Invasive Carcinoma in Situ and/or High-Grade Papillary Disease of the Bladder Treated With BCG Current proprietary name Already available biosimilars / generics Proprietary name Vicinium Manufacturer Sesen Bio Portfolio holder Mechanism of action Antibody-drug conjugate Route of administration Intravesical Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Protein synthesis inhibitors. Ook bekend als VB4-845. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date 2020 Expected Registration 2021 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Blaasspoeling BCG Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Zal in de toekomst ook concurrentie krijgen van immuuntherapie. Duration of treatment Frequency of administration Dosage per administration 30 mg References NCT02449239; NCT03258593 Additional remarks Phase III clinical trial: Experimental: Vicinium: - Induction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks. - Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks. Expected patient volume per year Patient volume < 1,500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; expertopinie Additional remarks Totaal aantal patiënten met invasief blaaskanker: 3.337. De inschatting is dat hier van ongeveer 1.500 patiënten gediagnosticeerd worden met hooggradig niet-spierinvasief blaascarcinoom (HG-NMIBC). Een deel hiervan krijgt BCG spoeling na een transurethrale Resectie van de blaas. Nadere toelichting schatting 1500 patiënten: In de afgelopen jaren kregen zo’n 700 patiënten met een in situ of T1 tumor een BCG-spoeling en zo'n 850 patiënten met een high-grade tumor. 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 Yes Indication extensions Phase II/III Head and neck cancer References SPS Additional remarks Other information Additional remarks