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Catequentinib

Medicine

Extended indication Catequentinib monotherapy for first line, second line treatment of unresectable, locally advanced or metastatic Alveolar soft part sarcoma in adults a
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Catequentinib
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Oncology other
Extended indication Catequentinib monotherapy for first line, second line treatment of unresectable, locally advanced or metastatic Alveolar soft part sarcoma in adults and elderly.
Manufacturer Advenchen
Mechanism of action Unknown
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity Unknown
ATMP No
Submission date March 2025
Expected Registration April 2026
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
Substantiation De Fase III APROMISS) studie loopt nog inclusie stopt in 2025. Catequentinib (AL3818; anlotinib in China) is een non-selectieve remmer van meerdere tyrosine kinase receptoren, waaronder (VEGFR-2, FLT1) en type 3 (VEGFR-3, FLT4). De verwachting is dat dit geneesmiddel de concurrentie aangaat met andere middelen als pazopanib en sunitinib.
Frequency of administration 1 times a day
Dosage per administration 12 mg
References NCT03016819
Additional remarks All subjects with ASPS will be assigned to the open-label AL3818 arm to receive 12 mg AL3818 capsules orally once daily in 21-day cycles (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).

Expected patient volume per year

Patient volume < 3

Market share is generally not included unless otherwise stated.
References NKR2021; Expert opinie
Additional remarks In 2021 waren er 313 wekedelen sarcomen van de extremiteiten gediagnosticeerd. ASPS is een zeer zeldzame vorm van soft tissue sarcoma: ASPS is one of the rarest sarcomas. 0,2% tot 1% van alle wekedelen sarcomen zijn ASPS.

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information