Extended indication

Extension of indication to include in combination with nivolumab the treatment of adult patients wit

Therapeutic value

No estimate possible yet

Registration phase

Clinical trials

Product

Active substance

Ipilimumab

Domain

Oncology

Reason of inclusion

Indication extension

Main indication

Lung cancer

Extended indication

Extension of indication to include in combination with nivolumab the treatment of adult patients with unresectable stage III NSCLC

Proprietary name

Yervoy

Manufacturer

BMS

Portfolio holder

BMS

Route of administration

Intravenous

Therapeutical formulation

Intravenous drip

Budgetting framework

Intermural (MSZ)

Registration

Registration route

Centralised (EMA)

Type of trajectory

Normal trajectory

ATMP

No

Submission date

March 2023

Expected Registration

December 2024

Orphan drug

No

Registration phase

Clinical trials

Therapeutic value

Current treatment options

Durvalumab

Therapeutic value

No estimate possible yet

Substantiation

Er zal mogelijk substitutie plaatsvinden met durvalumab. Er wordt verwacht dat bij oudere patiënten wel gepast gebruik zal plaatsvinden door de mogelijke toxiciteit van de ipi-nivo combinatie behandeling na radiotherapie.

Expected patient volume per year

Patient volume

< 2,231

Market share is generally not included unless otherwise stated.

References
NKR 2021 (1); Expert opinie (2)
Additional remarks
In 2021 werden er 2.231 patiënten gediagnosticeerd met de indicatie stadium 3 NSCLC. Er wordt echter verwacht dat het volume lager zal uitvallen doordat niet alle oudere patiënten deze behandeling zullen krijgen (2).

Expected cost per patient per year

There is currently nothing known about the expected cost.

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.