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Capivasertib

Extended indication Locally advanced (inoperable) or metastatic Hormone Receptor Positive, Human Epidermal Growth Factor
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Capivasertib
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Breast cancer
Extended indication Locally advanced (inoperable) or metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) breast cancer following recurrence or progression on or after endocrine therapy.
Manufacturer AstraZeneca
Portfolio holder AstraZeneca
Mechanism of action Other
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 2023
Expected Registration June 2024
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Het is onduidelijk of er wel of geen CDK4/6 remmer werd gegeven. In de overall populatie werd weinig winst gezien, maar wel in de lijn waarin een CDK4/6remmer gegeven is. De plaatsbepaling hangt af van de SONIA studie.
Frequency of administration 2 times a day
Dosage per administration 400 mg (2 tabletten van 200 mg twee keer per dag = totale dosering per dag is 800 mg) op dag 1 tot 4 van elke week tot aan progressie. In combinatie met fulvestrant in lijn met label.
References CAPItello-291 (NCT04305496)

Expected patient volume per year

References IKNL 2020 (1) Pakketadvies palbociclib (2)
Additional remarks Invasief mammacarcinoom: HR+HER- stadium 1; 5.026 patiënten, stadium 2; 3.938 patiënten, stadium 3; 994 patiënten en stadium 4; 597 patiënten (1) Het betreft locally advanced / metastatic om die reden gaan wij uit van stadium 3 en 4 (994+597=1.591 patiënten). In ongeveer 20% van de patiënten met vroege borstkanker zal de ziekte terugkeren als gemetastaseerde ziekte (5.026+3.938)*20%=1.793 patiënten. (2) In totaal komen er dan ook voor deze indicatie 1.793+1591=3.384 maximaal in aanmerking

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 Yes
Indication extensions Prostaatkanker (fase III)
References Adis Insight

Other information

There is currently no futher information available.