Extended indication

in combination with etoposide and platinum chemotherapy, is indicated for the first line treatment o

Therapeutic value

No estimate possible yet

Registration phase

Clinical trials

Product

Active substance

Pembrolizumab / vibostolimab

Domain

Oncology

Reason of inclusion

New medicine (specialité)

Main indication

Lung cancer

Extended indication

in combination with etoposide and platinum chemotherapy, is indicated for the first line treatment of adults with extensive stage small cell lung cancer (ES SCLC)

Manufacturer

MSD

Portfolio holder

MSD

Route of administration

Intravenous

Budgetting framework

Intermural (MSZ)

Registration

Registration route

Centralised (EMA)

Type of trajectory

Normal trajectory

Particularity

New therapeutical formulation

ATMP

No

Submission date

January 2025

Expected Registration

2025

Orphan drug

No

Registration phase

Clinical trials

Therapeutic value

Current treatment options

none, atezolizumab is not reimbursed in NL

Therapeutic value

No estimate possible yet

Substantiation

De studie is gestopt vanwege bijwerkingen en resultaten.

Duration of treatment

Maximal 2 year / years

Frequency of administration

1 times every 3 weeks

Dosage per administration

200 mg / 200mg

References
NCT05224141

Expected patient volume per year

Patient volume

< 1,160

Market share is generally not included unless otherwise stated.

References
1: NKR2021.
Additional remarks
In 2021 waren er in totaal 1.646 patiënten met kleincellig longcarcinoom. Hiervan betrof het in 1.160 patiënten met een stadium 4 carcinoom.

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.