Rociletinib

Extended indication	EGRF positieve non-small cell lung cancer (NSCLC).
Therapeutic value	No judgement
Registration phase	Clinical trials

Product

Active substance	Rociletinib
Domain	Oncology and Hematology
Main indication	Lung cancer
Extended indication	EGRF positieve non-small cell lung cancer (NSCLC).
Manufacturer	Clovis
Route of administration	Oral
Budgetting framework	Intermural (MSZ)

Registration route	Centralised (EMA)
Particularity	New medicine
Expected Registration	2020
Orphan drug	No
Registration phase	Clinical trials
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	No judgement

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.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.