Fruquintinib

Extended indication	Treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine, oxaliplatin, and irinotecan based chemotherapy, an anti VEGF therapy, and, if RAS wild type, an anti-EGFR therapy.
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Fruquintinib
Domain	Oncology
Reason of inclusion	New medicine (specialité)
Main indication	Colon cancer
Extended indication	Treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine, oxaliplatin, and irinotecan based chemotherapy, an anti VEGF therapy, and, if RAS wild type, an anti-EGFR therapy.
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	June 2023
Expected Registration	July 2024
Registration phase	Registration application pending

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).
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.

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.

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.