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Olaparib

Lynparza

Extended indication Extension of indication for Lynparza in combination with Imfinzi for the maintenance treatment of ad
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Olaparib
Domain Oncology
Reason of inclusion Indication extension
Main indication Cervical cancer
Extended indication Extension of indication for Lynparza in combination with Imfinzi for the maintenance treatment of adult patients with newly diagnosed advanced or recurrent endometrial cancer following treatment with Imfinzi and platinum-based chemotherapy
Proprietary name Lynparza
Manufacturer AstraZeneca
Portfolio holder AstraZeneca
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date October 2023
Expected Registration August 2024
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation In de intention-to-treat-populatie werd een statistisch significant PFS-voordeel waargenomen in de durvalumab- arm (hazard ratio [HR], 0,71 [95% CI, 0,57 tot 0,89]; P = 0,003) en de durvalumab + olaparib-armen (HR, 0,55). [95% CI, 0,43 tot 0,69]; P < 0,0001) versus controle. De durvalumab + olaparib-arm had een statistisch significant 45% lager risico op ziekteprogressie of overlijden versus de controlegroep (HR, 0,55 [95% CI, 0,43 tot 0,69]; P < 0,0001; mediane PFS 15,1 versus 9,6 maanden. Vooraf gespecificeerde, verkennende subgroepanalyses toonden PFS-voordeel aan bij dMMR (HR [durvalumab versus controle], 0,42 [95% CI, 0,22 tot 0,80]; HR [durvalumab + olaparib versus controle], 0,41 [95% BI, 0,21 tot 0,75]) en pMMR-subgroepen (HR [durvalumab versus controle], 0,77 [95% BI, 0,60 tot 0,97]; HR [durvalumab + olaparib versus controle] 0,57; [95% BI, 0,44 tot 0,73]); en in PD-L1-positieve subgroepen (HR [durvalumab versus controle], 0,63 [95% BI, 0,48 tot 0,83]; HR [durvalumab + olaparib versus controle], 0,42 [95% BI, 0,31 tot 0,57]).
References NCT04269200 https://ascopubs.org/doi/full/10.1200/JCO.23.02132

Expected patient volume per year

Patient volume

< 583

Market share is generally not included unless otherwise stated.
References (1) NKR 2021 (2) Huijgens AN, Mertens HJ. Factors predicting recurrent endometrial cancer. Facts Views Vis Obgyn. 2013;5(3):179- (3) https://pubmed.ncbi.nlm.nih.gov/24753943/
Additional remarks Er waren in 2021 in totaal 2.221 patiënten met een endometriumcarcinoom (1). De verdeling van het aantal patiënten per FIGO stadium is 80,9% voor stadium I, 4,8% stadium II, 11,5% stadium III en 2,9% stadium IV (2). De kans op recidief is 6,5% (stadium I), 20% (stadium II), 37,5% (stadium III) en 66,7% (stadium IV) (3). Dit betekent dat er ongeveer 583 patiënten in aanmerking komen.

Expected cost per patient per year

References G-Standaard
Additional remarks €2.490,00 per verpakking van 56 tabletten

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.