Extended indication NUT midline carcinoma (NMC) (een vorm van "squamous cell epithelial cancer")
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance GSK525762
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Oncology other
Extended indication NUT midline carcinoma (NMC) (een vorm van "squamous cell epithelial cancer")
Manufacturer GSK
Mechanism of action BET inhibitor
Route of administration Oral
Therapeutical formulation Unknown
Budgetting framework Intermural (MSZ)
Additional remarks BET family bromodomain inhibitor

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity Unknown
ATMP Unknown
Submission date 2020
Expected Registration 2021
Orphan drug Unknown
Registration phase Clinical trials

Therapeutic value

Therapeutic value No judgement

This assessment does not indicate any potential inclusion in the package.

References NCT01587703
Additional remarks gezien de vroege fase van klinische studies is het nog onduidelijk welke therapeutische waarde het middel mogelijk heeft en wat het behandelschema zal worden.

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Additional remarks Betreft een ultra-zeldzame vorm van kanker, zeer klein aantal patiënten verwacht die hiervoor in aanmerking gaan komen.

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Yes
Indication extensions Lopende studies o.a. naar het effect bij Solide tumoren
References clinicaltrials.gov

Other information