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Olaparib

Lynparza

Extended indication treatment of adults with metastatic castration resistant prostate cancer (mCRPC), with Lynparza in c
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Olaparib
Domain Oncology
Reason of inclusion Indication extension
Main indication Prostate cancer
Extended indication treatment of adults with metastatic castration resistant prostate cancer (mCRPC), with Lynparza in combination with abiraterone and prednisone or prednisolone
Proprietary name Lynparza
Manufacturer AstraZeneca
Mechanism of action PARP inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date January 2022
Expected Registration November 2022
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
Frequency of administration 2 times a day
Dosage per administration Olaparib 300 mg for days 1-28 in 28 day cycles.
References NCT03012321

Expected patient volume per year

References NKR 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 8226 in totaal. Na starten van anti hormonale therapie zal maximaal 20% van de patiënten binnen vijf jaar CRPC ontwikkelen (1.645 patiënten).

Expected cost per patient per year

Cost < 39,922.00
References G-standaard, november 2021.
Additional remarks Uitgaande van 12 maanden behandelduur.

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.