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.