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Osimertinib

Tagrisso

Extended indication Neoadjuvant Osimertinib as Monotherapy or in Combination With Chemotherapy Versus Standard of Care C
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Osimertinib
Domain Oncology
Reason of inclusion Indication extension
Main indication Lung cancer
Extended indication Neoadjuvant Osimertinib as Monotherapy or in Combination With Chemotherapy Versus Standard of Care Chemotherapy Alone for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer
Proprietary name Tagrisso
Manufacturer AstraZeneca
Portfolio holder AstraZeneca
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2024
Expected Registration September 2025
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Er zijn nog geen studie resultaten bekend.

Expected patient volume per year

Patient volume

119 - 237

Market share is generally not included unless otherwise stated.
References NKR2022 (1); Expertopinie (2); Pakketadvies sluisgeneesmiddel osimertinib (Tagrisso®) bij de eerstelijnsbehandeling van patiënten met gevorderde of gemetastaseerde niet-kleincellige longkanker (NSCLC) met activerende EGFR-mutaties (3).
Additional remarks In 2022 werden er in Nederland 2.372 mensen met niet-kleincellig longcarcinoom, stadium I en II, gediagnosticeerd (1). 70% betreft adenocarcinoom (2). Het aantal NSCLC patiënten met EGFR betreft zo'n 5 tot 10% van deze patiënten (3).

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.