Extended indication For the treatment of patients with previously treated unresectable locally advanced or metastatic co
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Atezolizumab
Domain Oncology and Hematology
Main indication Colon cancer
Extended indication For the treatment of patients with previously treated unresectable locally advanced or metastatic colorectal adenocarcinoma 3L.
Proprietary name Tecentriq
Manufacturer Roche
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks An engineered anti-PD-L1 antibody

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Submission date August 2018
Expected Registration June 2019
Orphan drug No
Registration phase Clinical trials
Additional remarks Sluis-product, financieel arrangement van toepassing.

Therapeutic value

Current treatment options Regorafenib
Therapeutic value No judgement
Frequency of administration 1 times every 3 weeks
Dosage per administration 1200 mg
References NCT02788279

Expected patient volume per year

References NKR
Additional remarks 2632 diagnoses darmkanker stadium 4 in 2016. Gezien 3L behandeling ligt het patiëntvolume een stuk lager.

Expected cost per patient per year

Cost 40,000.00
References Medicijnkosten.nl
Additional remarks Flacon 1200 mg kost €4.393,70. Uitgaande van 26 weken behandelduur (obv Cetuximab) zijn er 9 flacons nodig: €39.543,30.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

Off label use No

Indication extension

Indication extension Yes
Indication extensions Gastric and TNBC
References Fabrikant
Additional remarks Deze indicatie-uitbreidingen worden later verwacht (2020).

Other information

There is currently no futher information available.