Extended indication Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metast
Therapeutic value No estimate possible yet
Registration phase Registered

Product

Active substance Futibatinib
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Oncology other
Extended indication Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
Manufacturer Taiho Oncology
Mechanism of action Receptor antagonist
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date May 2022
Expected Registration June 2023
Orphan drug Yes
Registration phase Registered
Additional remarks Positieve CHMP-opinie april 2023

Therapeutic value

Current treatment options Gemcitabine en cisplatine in de eerstelijn.
Therapeutic value No estimate possible yet
Substantiation Pemigatinib is een vergelijkbaar geneesmiddel dat eerder geen positief cieBOM advies ontving. De resultaten van futibatinib lijken vooralsnog beter. 43 van de 103 patiënten (42%; 95% confidence interval, 32 tot 52) vertoonden een respons, de mediane duur van respons was 9,7 maanden. De mediane follow-up was 17,1 maanden, de mediane progressie-vrije survival was 9,0 maanden en de overall survival was 21,7 maanden.
References NCT04093362
Additional remarks Patients will receive futibatinib at an oral dose of 20mg, administered daily (QD) on every day of a 21-day cycle.

Expected patient volume per year

Patient volume

10

Market share is generally not included unless otherwise stated.

References NKR; Plentz RR. Systemic Therapy of Cholangiocarcinoma. Visc Med. 2016;32(6):427–430. (Record Pemigatinib)
Additional remarks Er zijn ongeveer 700 patiënten in Nederland gediagnosticeerd met een cholangiocarcinoom. Hiervan betreft het in 36% een intra hepatisch carcinoom (n=252), waarvan 237 patiënten unresectable/relapsed resectable zijn. Hiervan zal ongeveer 50% chemotherapie ontvangen (n-119). 50% van de patiënten zal getest worden op een FGFR2 mutatie, waarvan ongeveer 10% tot 16% positief is, dit betekent dat er rond de 10 patiënten in aanmerking komen voor deze behandeling. Deze 10 patiënten zullen verdeeld worden tussen pemigatinib en futibatinib.

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 No
References adisinsight
Additional remarks Meerdere lopende fase 2 studies.

Other information

There is currently no futher information available.