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Durvalumab

Imfinzi

Extended indication Non-small cell lung cancer (NSCLC), 1L monotherapy
Therapeutic value No judgement
Total cost 48,459,960.00
Registration phase Clinical trials

Product

Active substance Durvalumab
Domain Oncology and Hematology
Main indication Lung cancer
Extended indication Non-small cell lung cancer (NSCLC), 1L monotherapy
Proprietary name Imfinzi
Manufacturer AstraZeneca
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks PD-L1 remmer

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials
Additional remarks Fabrikant: "Imfinzi plus tremelimumab combination did not meet a primary endpoint of progression-free survival compared to chemotherapy. The MYSTIC trial continues as planned to assess the additional primary endpoints of overall survival for Imfinzi monotherapy and for the Imfinzi plus tremelimumab combination."

Therapeutic value

Current treatment options Platinum doublet chemotherapie / pembrolizumab voor PD-L1 > 50%.
Therapeutic value No judgement
Frequency of administration 1 times every 2 weeks
Dosage per administration 10 mg/kg
References NCT02453282

Expected patient volume per year

Patient volume

198 - 988

Market share is generally not included unless otherwise stated.
References De fabrikant geeft aan dat ze verwachten dat er 988 patiënten binnen de indicatie zullen vallen waarvan 198 mogelijk daadwerkelijk behandeld zullen worden.

Expected cost per patient per year

Cost 81,720.00
References Fabrikant; Pakketadvies pembrolizumab (Keytruda®) 2016 Zorginstituut Nederland Diemen
Additional remarks Naar verwachting is de maandelijkse kostprijs vergelijkbaar met maandelijkse kostprijs van pembrolizumab (€6.810).

Potential total cost per year

Total cost

48,459,960.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

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.