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Talazoparib

Talzenna

Extended indication

Talzenna is indicated in combination with enzalutamide for the treatment of adult patients with meta

Therapeutic value

Possible added value
Registration phase

Positive CHMP opinion

Product

Active substance

Talazoparib
Domain

Oncology
Reason of inclusion

Indication extension
Main indication

Prostate cancer
Extended indication

Talzenna is indicated in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.
Proprietary name

Talzenna
Manufacturer

Pfizer
Portfolio holder

Pfizer
Mechanism of action

PARP 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

February 2023
Expected Registration

January 2024
Orphan drug

No
Registration phase

Positive CHMP opinion
Additional remarks 
Fabrikant verwacht registratie in januari 2024

Therapeutic value

Therapeutic value

Possible added value
Substantiation

Mediane behandelduur in de talazoparib/enzalutamide-arm was 19,8 maanden voor talazoparib en 22,2 maanden voor enzalutamide. Mediane behandelduur in de placebo/enzalutamide-arm was 16,1 maanden voor placebo en 16,6 maanden voor enzalutamide.
Duration of treatment

Not found
Dosage per administration

Starting dose talazoparib 0,5MG per day with enzalutimide 160MG per day
References 
Agarwal et al (2023): Talazoparib plus enzalutamide in men with first-line metastatic castration-resistant prostate cancer (TALAPRO-2): a randomised, placebo-controlled, phase 3 trial, https://doi.org/10.1016/
S0140-6736(23)01055-3

Expected patient volume per year

Patient volume

< 3,000

Market share is generally not included unless otherwise stated.
References 
NKR, CAPRI en Zinnige Zorg verbetersignalement: Zinnig gebruik van geneesmiddelen bij patiënten met castratie refractair prostaatcarcinoom
Additional remarks 
Totaal aantal nieuwe prostaatkankerpatiënten per jaar is meer dan 12.000. Patiënten geregistreerd in de NKR 2016 met "cM0cNX, cM0cN0, cMcN1, cM1, pM1" betreft 8.226 in totaal. Het gaat hierbij om zo’n 2.400-3.000 CRPC patiënten (bron: CAPRI). Gezien bijna alle patiënten met CRPC uitzaaiingen hebben is de verwachting bijna de gehele groep mCRPC patiënten betreft.

Expected cost per patient per year

References 
Taxe november 2023
Additional remarks 
De lijstprijs van Talzenna 0,25mg (x30) = €1.778,57 (exclusief BTW). Een behandeling van 0,5mg per dag zou neerkomen op €118,57 per dag. Behandelduur voor prostaatkanker is op dit moment nog niet bekend.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

Off label use

No

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.