GSK2857916 Medicine 13 December 2018 Extended indication 4L Relapsed/refractory Multiple Myeloma Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance GSK2857916 Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Multiple Myeloma Extended indication 4L Relapsed/refractory Multiple Myeloma Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer GSK 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 humanized IgG1, an Antibody Drug Conjugated to Microtubule-Disrupting Agent Directed Against B-Cell Maturation Antigen (BCMA). Registration Registration route Centralised (EMA) Type of trajectory Accelerated assessment Particularity New medicine with Priority Medicines (PRIME) ATMP Unknown Submission date August 2019 Expected Registration August 2020 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks 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 1 times every 3 weeks Dosage per administration References NCT03525678 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks NKR (2015): 1.242 patienten met multipel myeloma(max). Gezien relapsed / refractory en overige behandelingen zal het realistische volume echter een stuk lager liggen. 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 3L, 2L, 1L References https://www.gsk.com/media/5028/q2-2018-slides-hal-barron.pdf Additional remarks Other information Additional remarks