Rovalpituzumab tesirine Medicine 09 January 2018 Extended indication Small-cell lung cancer (SCLC), 3L. Therapeutic value No judgement Total cost Registration phase Withdrawn Product Active substance Rovalpituzumab tesirine Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Small-cell lung cancer (SCLC), 3L. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Abbvie Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug Yes Registration phase Withdrawn Reimbursement Medicine sluice Additional remarks Klinische studies zijn stopgezet. 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 56 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Expertopinie Additional remarks In 2016 werden er 1.118 diagnoses stadium 4 SCLC geregistreerd. Hiervan is de inschatting dat ongeveer 5% een behandeling in de derde lijn krijgt (56) 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 No Indication extensions References SPS Additional remarks geen fase III studies voor andere indicaties dan in de horizonscan Other information Additional remarks