Depatuxizumab mafodotin Medicine 09 January 2018 Extended indication Treatment of patients with newly diagnosed EGFR-amplified glioblastoma in combination with temozolomide and radiotherapy. Therapeutic value No judgement Total cost Registration phase Withdrawn Product Active substance Depatuxizumab mafodotin Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Brain cancer Extended indication Treatment of patients with newly diagnosed EGFR-amplified glioblastoma in combination with temozolomide and radiotherapy. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Abbvie Portfolio holder Mechanism of action Antibody-drug conjugate 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 Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase Withdrawn Reimbursement Medicine sluice Additional remarks Studie heeft de primaire eindpunten niet gehaald. Abbvie heeft alle studies stopgezet in mei 2019. 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 < 200 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Hatanpaa et al. Neoplasia. 2010 Sep; 12(9): 675–684 Additional remarks De incidentie ligt jaarlijks rond de 700 en daar komen zeker 100 cases bij na progressie. Als we uitgaan van 40% EGFR-amplificatie en vervolgens 60% van patiënten dat in aanmerking komt voor chemotherapie, dan zijn dat ongeveer 200 cases op jaarbasis. 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 Yes Indication extensions Glioblastoma multiforme, relapsed - second and subsequent line References SPS Additional remarks Other information Additional remarks