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.