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Catequentinib

Extended indication Catequentinib monotherapy for first line, second line treatment of unresectable, locally advanced or
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
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
ATMP No
Submission date March 2025
Expected Registration April 2026
Orphan drug Yes
Registration phase Clinical trials
Additional remarks Indieningsdatum en verwachte registratie op basis van primary completion datum in december 2024.

Therapeutic value

Therapeutic value No estimate possible yet
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 (APROMISS)
Additional remarks All subjects with ASPS will be assigned to the open-label AL3818 arm to receive 12mg 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; Expertopinie
Additional remarks In 2021 waren er 313 wekedelen sarcomen van de extremiteiten gediagnosticeerd. ASPS is een zeer zeldzame vorm van soft tissue sarcoma. 0,2% tot 1% van alle wekedelen sarcomen zijn ASPS.

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.