Rociletinib Medicine 09 January 2018 Extended indication EGRF positieve non-small cell lung cancer (NSCLC). Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Rociletinib Domain Oncology and Hematology Reason of inclusion Main indication Lung cancer Extended indication EGRF positieve non-small cell lung cancer (NSCLC). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Clovis Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity New medicine ATMP Unknown Submission date Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice 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 Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume 0 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice 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 Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks