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Rociletinib

Extended indication EGRF pos NSCLC.
Therapeutic value No judgement

Product

Active substance Rociletinib
Domain Oncology and Hematology
Main indication Lung cancer
Extended indication EGRF pos NSCLC.
Manufacturer Clovis
Route of administration Oral
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Expected Registration 2020
Orphan drug No
Additional remarks Meerdere studies teruggetrokken, 1 PhIII studie loopt nog: Monotherapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR Non-small Cell Lung Cancer (NSCLC) After Failure of at Least 1 Previous EGFR-directed Tyrosine Kinase Inhibitor (TKI) and Platinum-doublet Chemotherapy

Therapeutic value

Therapeutic value No judgement
Duration of treatment Not found

Expected patient volume per year

Patient volume

0 - 796

Market share is generally not included unless otherwise stated.
References Ned Tijdschr Geneeskd. 2011;155:A2554; Fabrikant
Additional remarks NKR 2015: 5304 diagnoses niet-kleincellig longcarcinoom stadium 4. Naar schatting komt bij 10-15% van de NSCLCs een aktiverende EGFR-mutatie voor. Fabrikant geeft aan dat de huidige studies worden stopgezet met uitzondering van de patiënten die momenteel baat hebben bij een behandeling.

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.