Extended indication Non Muscle-Invasive Carcinoma in Situ and/or High-Grade Papillary Disease of the Bladder Treated Wit
Therapeutic value No judgement
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
Proprietary name Vicinium
Manufacturer Sesen Bio
Mechanism of action Antibody-drug conjugate
Route of administration Intravesical
Budgetting framework Intermural (MSZ)
Additional comments Protein synthesis inhibitors. Ook bekend als VB4-845.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date 2020
Expected Registration 2021
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Blaasspoeling BCG
Therapeutic value No judgement
Substantiation Zal in de toekomst ook concurrentie krijgen van immuuntherapie.
Dosage per administration 30 mg
References NCT02449239; NCT03258593
Additional comments 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.

References NKR; expertopinie
Additional comments 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

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Phase II/III Head and neck cancer
References SPS

Other information

There is currently no futher information available.