Extended indication 1L squamous NSCLC (combi): In combination with carboplatin and either paclitaxel or nab-paclitaxel f
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Tislelizumab
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Lung cancer
Extended indication 1L squamous NSCLC (combi): In combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of locally advanced or metastatic squamous NSCLC in adults
Manufacturer Novartis
Portfolio holder Novartis
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Injection / infusion solution
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date March 2022
Expected Registration June 2023
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Chemo-immuno
Therapeutic value No estimate possible yet
Duration of treatment Median 8 month / months
Frequency of administration 1 times every 3 weeks
Dosage per administration 200mg
References RATIONALE 307 studie (NCT03594747)
Additional comments Voor behandelduur vooralsnog mPFS gebruikt

Expected patient volume per year

Patient volume

0 - 497

Market share is generally not included unless otherwise stated.

References Pakketadvies (en Horizonscan) atezolizumab.
Additional comments Jaarlijks presenteren er ongeveer 4.500 patiënten per jaar met NSCLC stadium IV. Van deze groep heeft ongeveer 35% plaveiselcelcarcinoom (1.575). Hiervan ontvangt ongeveer 60% een eerstelijnsbehandeling (945) waarvan 52,6% chemotherapie (497). Deze patiënten komen in aanmerking voor een behandeling met immuuntherapie en/of chemotherapie (immunotherapie) in de 1L. Slechts een (zeer) klein deel van de in aanmerking komende patiënten zal behandeld worden met tislelizumab.

Expected cost per patient per year

Additional comments Nog onbekend

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

Off label use No

Indication extension

Indication extension Yes
Indication extensions Verschillende klinische studies lopen binnen long kanker en gastrointestinale tumortypes

Other information

There is currently no futher information available.