Extended indication

Extension of indication to include the treatment of adult patients with anaplastic lymphoma kinase (

Therapeutic value

No estimate possible yet

Registration phase

Registration application pending

Product

Active substance

Lorlatinib

Domain

Oncology and Hematology

Reason of inclusion

Indication extension

Main indication

Lung cancer

Extended indication

Extension of indication to include the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.

Proprietary name

Lorviqua

Manufacturer

Pfizer

Mechanism of action

Tyrosine kinase inhibitor

Route of administration

Oral

Therapeutical formulation

Tablet

Budgetting framework

Intermural (MSZ)

Additional comments
ALK en ROS1 inhibitor.

Registration

Registration route

Centralised (EMA)

Type of trajectory

Normal trajectory

ATMP

No

Submission date

March 2021

Expected Registration

February 2022

Orphan drug

No

Registration phase

Registration application pending

Therapeutic value

Current treatment options

Crizotinib, alectinib.

Therapeutic value

No estimate possible yet

Substantiation

In vergelijking met crizotinib is er een beter progressie vrije overleving geconstateerd met minder metastases. Deze uitkomsten zijn vergelijkbaar met alectinib. Mogelijk zal het ook ingezet kunnen worden op het moment dat alectinib niet effectief is.

References
NCT03052608

Expected patient volume per year

Patient volume

67

Market share is generally not included unless otherwise stated.

References
NKR; Sweis (2016). Concurrent EGFR Mutation and ALK Translocation in Non-Small Cell Lung Cancer. Cureus, 8(2), e513. https://doi.org/10.7759/cureus.513
Additional comments
In 2018 waren er 5.062 patiënten met NSCLC stadium IV. Hiervan zal 60% een eerstelijnsbehandeling krijgen (3.337). Uit studies blijkt dat ongeveer 2% van de patiënten een ALK mutatie bezit. Dit betekent dat er mogelijk 67 patiënten in aanmerking zullen komen voor behandeling.

Expected cost per patient per year

References
medcijnkosten.nl
Additional comments
Gemiddelde prijs per 30 stuks Lorviqua, tablet 100mg 	€ 4.854,60

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.