Extended indication Extension of indication to include first-line treatment of adult patients with non-small cell lung c
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Atezolizumab
Domain Oncology
Reason of inclusion Indication extension
Main indication Lung cancer
Extended indication Extension of indication to include first-line treatment of adult patients with non-small cell lung cancer (NSCLC) who are ineligible for platinum-based chemotherapy and who do not have EGFR mutant or ALK-positive disease, who have: locally advanced unresectable NSCLC not amenable for definitive chemoradiotherapy, or metastatic NSCLC.
Proprietary name Tecentriq
Manufacturer Roche
Portfolio holder Roche
Mechanism of action PD-1 / PD-L1 inhibitor
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)
ATMP No
Submission date September 2023
Expected Registration September 2024
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
References NCT03191786

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost 40,000.00 - 60,000.00
Additional remarks Op basis van lijstprijs per vial (1.200 mg atezolizumab) van €4.145, 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 2020).

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.