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.