Extended indication Unresectable Advanced Melanoma (1L) in combination with pembrolizumab.
Therapeutic value No estimate possible yet
Total cost 19,180,000.00
Registration phase Clinical trials

Product

Active substance Lenvatinib
Domain Oncology
Reason of inclusion Indication extension
Main indication Skin cancer
Extended indication Unresectable Advanced Melanoma (1L) in combination with pembrolizumab.
Proprietary name Lenvima
Manufacturer Eisai
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional comments Exacte indicatiestelling nog niet bekend.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date 2022
Expected Registration 2023
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options In de eerste lijn zijn zowel combinatiebehandeling met BRAF- en MEK-remmers als behandeling met checkpointremmers (nivolumab, ipilumumab, pembrolizumab) valide keuzes als het gaat om een gemetastaseerd melanoom met een BRAF-V600E- of BRAF-V600K-mutatie. In BRAFwt-tumoren zijn pembrolizumab, nivolumab en de combinatie nivolumab en ipilimumab de standaardopties.
Therapeutic value No estimate possible yet
Duration of treatment Not found
Frequency of administration 1 times a day
Dosage per administration 20mg (= maximum startdosering. Dosisreductiestappen 14mg, 10mg, 8mg)
References "Bron 1) Studie: MK-7902-003/E7080-G000-312/LEAP-003 (NCT03820986) Bron 2) Studie: E7080-A001-111/KEYNOTE-146 (NCT02501096)"

Expected patient volume per year

Patient volume

< 700

Market share is generally not included unless otherwise stated.

References DMTR(1);
Additional comments Er worden in de DMTR zo’n nieuwe 800-900 patiënten per jaar met gemetastaseerd melanoom geregistreerd waarvan er circa 700 met systeemtherapie behandeld worden (1).

Expected cost per patient per year

Cost 27,400.00
References G-standaard
Additional comments AIP per april 2021: €1.780,12 verpakking á 30 capsules (4mg of 10mg). Uitgaande van een behandeling van maximaal 20mg/dag (= maximaal 2 capsules) voor 7,6 maanden (bron 2) zou dat gaan om €27.400 per patiënt per jaar.

Potential total cost per year

Total cost

19,180,000.00

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 Indicatie uitbreidingen worden weergegeven in de Horizonscan Geneesmiddelen.

Other information

There is currently no futher information available.