Expand all sections

Mitomycine extended release

VesiGel

Extended indication Low-grade intermediate-risk nonmuscle-invasive bladder cancer (LG IR NMIBC)
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Mitomycine extended release
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Bladder cancer
Extended indication Low-grade intermediate-risk nonmuscle-invasive bladder cancer (LG IR NMIBC)
Proprietary name VesiGel
Manufacturer Urogen
Mechanism of action Other, see general comments
Route of administration Intravesical
Therapeutical formulation Gel
Budgetting framework Intermural (MSZ)
Additional remarks VesiGel (UGN-102) is een formulering van mitomycine op basis van een hydrogel met langdurige afgifte.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New therapeutical formulation
ATMP No
Submission date 2025
Expected Registration 2026
Orphan drug No
Registration phase Clinical trials
Additional remarks Uitgaande van de ENVISION Fase III-trial, verwacht UroGen in september een NDA in te dienen bij de FDA met een mogelijke registratie in het eerste kwartaal van 2025. Primary completion (actual): 25 april 2023.

Therapeutic value

Current treatment options Conventioneel mitomycine
Therapeutic value No estimate possible yet
Substantiation De ATLAS trial (UGN-102 for the management of low-grade intermediate-risk nonmuscle-invasive bladder cancer versus immediate transurethral resection) is voortijdig gestaakt vanwege verandering development strategie van de firma. De resultaten van de fase III ENVISION trial zijn nog niet bekend.
References NCT04688931 (ATLAS); NCT05243550 (ENVISION).

Expected patient volume per year

Patient volume

< 3,723

Market share is generally not included unless otherwise stated.
References NKR2024 (1).
Additional remarks In 2023 waren er 3.723 patiënten met niet-invasieve blaaskanker (NMIBC) (1).

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.