Extended indication In combination with cabozantinib patients with mCRPC previously treated with novel hormonal therapy
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Atezolizumab
Domain Oncology
Reason of inclusion Indication extension
Main indication Prostate cancer
Extended indication In combination with cabozantinib patients with mCRPC previously treated with novel hormonal therapy (NHT)
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 October 2023
Expected Registration June 2024
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet
Frequency of administration 1 times every 3 weeks
Dosage per administration 1200 mg
References NCT04446117

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 (1.200mg 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 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
References Product Development Portfolio

Other information

There is currently no futher information available.