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.