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Fruquintinib

Extended indication Fruzaqla as monotherapy is indicated for the treatment of adult patients with metastatic colorectal
Therapeutic value No estimate possible yet
Total cost 24,500,000.00
Registration phase Positive CHMP opinion

Product

Active substance Fruquintinib
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Colon cancer
Extended indication Fruzaqla as monotherapy is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan‑based chemotherapies, anti‑VEGF agents, and anti‑EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine‑tipiracil or regorafenib.
Manufacturer Takeda
Portfolio holder Takeda
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)
Particularity New therapeutical formulation
ATMP No
Submission date May 2023
Expected Registration July 2024
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP-opinie april 2024

Therapeutic value

Current treatment options None. There is no treatment for the patient population 4L after trifluridine/tipiracil (Lonsurf). Comparison of the therapeutic value of fruquintinib with placebo (FRESCO-2) therefore seems to be appropriate
Therapeutic value No estimate possible yet
Substantiation De eindpunten van de klinische studie werden behaald. Patiënten die met fruquintinib behandeld werden behaalden een mediane overall survival van 7,4 maanden (95% CI, 6.7-8.2) versus 4,8 maanden (95% CI, 4.0-5.8) met placebo (HR, 0.662; 95% CI, 0.549-0.800; P < .001). Daarnaast leidde de behandeling met fruquintinib tot een PFS van 3,7 maanden (95% CI, 3.5-3.8) versus 1,8 maanden (95% CI, 1.8-1.9) met placebo (HR, 0.321; 95% CI, 0.267-0.386; P<.001). In Nederland zal dit hoogstwaarschijnlijk alleen voldoen aan de PASKWIL criteria bij de RAS WT groep ( overall survival winst 3,3 maanden en HR 0,667).
Duration of treatment Average 12 week / weeks
Frequency of administration 1 times a day
Dosage per administration 5 mg
References Fase 3 FRESCO-2 trial (NCT04322539)
Additional remarks 3 weken elke dag behandeling en 1 week geen behandeling.

Expected patient volume per year

Patient volume

< 500

Market share is generally not included unless otherwise stated.
References IKNL2021 (1);
Additional remarks Gemetastaseerde coloncarcinoom betreft 2.085 patiënten in stadium 4 en gemetastaseerde rectumcarcinoom betreft 612 patiënten in stadium 4 in 2021. Samen gaat het dus om maximaal 2.697 patiënten in de eerstelijns. Er wordt verwacht dat er maximaal 500 patiënten in aanmerking komen op basis van gebruikersaantallen van Lonsurf. Dit volume zal lager uit vallen doordat het later in de lijn wordt ingezet en waarschijnlijk alleen de RAS WT patiënten in Nederland de indicatie krijgen.

Expected cost per patient per year

Cost < 49,000.00
References Fabrikant
Additional remarks De fabrikant geeft aan dat de exacte kosten nog niet bekend zijn. De kosten zullen in ieder geval niet meer bedragen dan €50.000 per patiënt per jaar.

Potential total cost per year

Total cost

24,500,000.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

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.