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Fruquintinib

Extended indication Metastatic colorectal cancer, 3L
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Fruquintinib
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Colon cancer
Extended indication Metastatic colorectal cancer, 3L
Manufacturer Hutchmed
Mechanism of action Receptor antagonist
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional remarks Oral VEGFR inhibitor

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2023
Expected Registration 2024
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation De eindpunten van de klinische studie werden behaald. Patiënten die met fruquintinib behandeld werden behaalden een mediane OS van 7,4 maanden (95% CI, 6.7-8.2) vs 4,8 maanden (95% CI, 4.0-5.8) met placebo (HR, 0.662; 95% CI, 0.549-0.800; P < .001). Daarnaast leide behandeling met fruquintinib tot een PFS van 3,7 maanden (95% CI, 3.5-3.8) vs 1,8 maanden (95% CI, 1.8-1.9) met placebo (HR, 0.321; 95% CI, 0.267-0.386; P < .001).
Frequency of administration 1 times a day
Dosage per administration 5 mg
References NCT04322539, NCT02314819
Additional remarks 3 weken elke dag behandeling en 1 week geen behandeling.

Expected patient volume per year

References IKNL
Additional remarks Gemetastaseerde coloncarcinoom betreft 1971 patiënten in stadium 4 en gemetastaseerde rectumcarcinoom betreft 630 patiënten in stadium 4 in 2020. Samen gaat het dus om maximaal 2601 patiënten in de 1L. Het patiëntvolume zal vanaf de tweedelijn lager zijn.

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 Yes
Indication extensions Fase III: Gastric cancer; Non-small cell lung cancer
References Adis Insight

Other information

There is currently no futher information available.