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AL102

Extended indication Desmoïd tumor (aggressive fibromatosis)
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance AL102
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Oncology other
Extended indication Desmoïd tumor (aggressive fibromatosis)
Manufacturer Ayala
Portfolio holder Ayala
Mechanism of action Other, see general comments
Budgetting framework Intermural (MSZ)
Additional remarks Werkingsmechanisme: AL102 is an inhibitor of gamma secretase-mediated Notch signaling.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2024
Expected Registration 2025
Orphan drug No
Registration phase Clinical trials
Additional remarks Estimated Primary Completion Date: January 12, 2025, maar mogelijk al eerder verwacht. Fase 2 en 3 studie besproken op ESMO 2022.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Op dit moment zijn er nog enkel resultaten over de veiligheid van het geneesmiddel bekend.
Frequency of administration 1 times a day
Dosage per administration 1,2 mg
References NCT04871282; https://www.globenewswire.com/news-release/2022/11/17/2558123/0/en/Ayala-Pharmaceuticals-Presents-Poster-on-AL102-in-Desmoid-Tumors-at-the-Connective-Tissue-Oncology-Society-CTOS-2022-Annual-Meeting.html

Expected patient volume per year

References https://www.desmoid.nl/desmoid-tumor/
Additional remarks Van alle wekedelen tumoren (sarcoom) is de desmoïd tumor (synoniem voor desmoïd-type fibromatose en agressieve fibromatose) een zeldzame variant, met ongeveer 3% van het totale aantal wekedelen tumoren, hetgeen betekent dat er in Nederland slechts enkele tientallen nieuwe patiënten per jaar worden gediagnosticeerd.

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 No
References AdisInsight
Additional remarks Geen andere lopende fase 2 / fase 3 studies

Other information

There is currently no futher information available.