Version 4

Catequentinib

Medicine

Extended indication Treatment of synovial sarcoma or leiomyosarcoma.
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Catequentinib
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Oncology other
Extended indication Treatment of synovial sarcoma or leiomyosarcoma.
Manufacturer Advenchen
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date July 2025
Expected Registration August 2026
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
Substantiation De Fase 3 (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 12mg
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

Potential total cost per year

Off label use

Indication extension

Other information