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Capivasertib

Truqap

Extended indication Capivasertib is indicated in combination with abiraterone as treatment for patients with de novo met
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Capivasertib
Domain Oncology
Reason of inclusion Indication extension
Main indication Prostate cancer
Extended indication Capivasertib is indicated in combination with abiraterone as treatment for patients with de novo metastatic hormone-sensitive prostate cancer characterized by PTEN deficiency
Proprietary name Truqap
Manufacturer AstraZeneca
Portfolio holder AstraZeneca
Route of administration Oral
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date March 2025
Expected Registration March 2026
Orphan drug No
Registration phase Clinical trials
Additional remarks In mei 2024 is het advies gegeven aan VWS om capivasertib in de sluis te plaatsen, voor zover verstrekt in het kader van geneeskundige behandelingen.

Therapeutic value

Current treatment options N.t.b.
Therapeutic value No estimate possible yet
Substantiation Er is nog geen effectiviteitsdata bekend. CAPItello-281 is op dit moment bezig.
Duration of treatment Maximal 12 month / months
Frequency of administration 2 times a day
References NCT04493853 (CAPItello-281)
Additional remarks Twee maal daags, 400mg (2 tablets of 200mg), iedere week op dag 1 tot 4 in een 28 daagse behandel cyclus. In combinatie met abiraterone.

Expected patient volume per year

Patient volume

146 - 291

Market share is generally not included unless otherwise stated.
References NKR2024 (1); Piombino et al. Cancers (Basel). 2023 (2); Van der Eecken et al. Eur. Urol. Oncol. 2021 (3).
Additional remarks In 2023 werden er in Nederland 14.561 mensen met prostaatkanker gediagnosticeerd (1). Gemetastaseerde hormoon sensitieve prostaatkanker (mHSPC) komt voor bij 5% tot10% van alle prostaatkankerdiagnoses (2). Bij 20% van de gevallen komt de PTEN-alteratie voor (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.