Lacutamab Medicine 07 December 2021 Extended indication Treatment of patients with Sézary Syndrome who have received at least two prior systemic therapies. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Lacutamab Domain Hematology Reason of inclusion New medicine (specialité) Main indication Indolent non-Hodgkin’s lymphoma Extended indication Treatment of patients with Sézary Syndrome who have received at least two prior systemic therapies. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Innate 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 Accelerated assessment Particularity New medicine with Priority Medicines (PRIME) ATMP No Submission date December 2022 Expected Registration September 2023 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks PRIME designation sinds november 2020. Primary completion date fase 2 TELLOMAK studie in maart 2022. Therapeutic value Current treatment options Systemische chemotherapie, mogamulizumab Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT03902184 Additional remarks Toediening is gedurende 5 weken iedere week, daarna 10 toedieningen elke twee weken en ten slotte elke 4 weken tot progressie of toxiciteit. Expected patient volume per year Patient volume < 10 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Incidentie CTCL in 2016 (NKR): 131. Expertopinie schat het aantal patiënten per jaar in op minder dan 10. De patiënt heeft eerst twee andere systemische behandeling ontvangen, een klein gedeelte zal dit overleven. 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 Mycosis fungoides; Peripheral T-cell lymphoma; Cutaneous T-cell lymphoma References Adis Insight Additional remarks Other information Additional remarks