Extended indication Small-cell lung cancer (SCLC), 3L.
Therapeutic value No judgement
Registration phase Unknown

Product

Active substance Rovalpituzumab tesirine
Domain Oncology and Hematology
Main indication Lung cancer
Extended indication Small-cell lung cancer (SCLC), 3L.
Proprietary name Rova-T
Manufacturer Abbvie
Mechanism of action Unknown
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity Unknown
ATMP Unknown
Expected Registration December 2018
Orphan drug Yes
Registration phase Unknown

Therapeutic value

Therapeutic value No judgement

This assessment does not indicate any potential inclusion in the package.

Expected patient volume per year

Patient volume < 60

Market share is generally not included unless otherwise stated.

References NKR
Additional remarks NKR 2015: 1192 kleincellig longcarcinoom stadium 4. Expertopinie: Ongeveer 5% 3L, 60 patiƫnten.

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information