Expand all sections

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.