Expand all sections

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.