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Atezolizumab

Tecentriq

Extended indication Atezolizumab plus chemotherapy for patients with early relapsing recurrent triple-negative breast cancer
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Atezolizumab
Domain Oncology
Reason of inclusion Indication extension
Main indication Breast cancer
Extended indication Atezolizumab plus chemotherapy for patients with early relapsing recurrent triple-negative breast cancer
Proprietary name Tecentriq
Manufacturer Roche
Portfolio holder Roche
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Concentrate for solution for infusion
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date December 2023
Expected Registration December 2024
Orphan drug No
Registration phase Clinical trials
Additional remarks Het is onzeker of deze indicatie uitbreiding doorgang vindt, aangezien de uitkomsten van de studie op dit moment onbekend zijn.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation This study will evaluate the efficacy and safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with inoperable recurrent triple-negative breast cancer (TNBC).
Frequency of administration 1 times every 3 weeks
Dosage per administration 1200 mg
References NCT03371017

Expected patient volume per year

References (1) IKNL 2021
Additional remarks In totaal 1.918 diagnoses mammacarcinoom HR-, HER- waarvan 418 diagnoses stadium III/IV (1).

Expected cost per patient per year

Cost 35,000.00 - 55,000.00
References https://zoek.officielebekendmakingen.nl/stcrt-2023-30299.html
Additional remarks Op basis van lijstprijs per vial (1.200mg atezolizumab) van €3.700. Kosten per patiënt per jaar zijn een inschatting in verband met onbekende behandelduur. Voor alle indicaties van atezolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met 31 december 2026). Zie publicatie in Staatscourant van 6 november 2023.  

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

Indication extension Yes
Indication extensions Verschillende indicaties in ontwikkeling
Additional remarks Product Development Portfolio

Other information

There is currently no futher information available.