Tafasitamab Medicine 10 June 2020 Extended indication is indicated in combination with lenalidomide followed by monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, autologous stem cell transplant (ASCT). Therapeutic value Possible added value Total cost Registration phase Registration application pending Product Active substance Tafasitamab Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Aggressive non-Hodgkin’s lymphoma Extended indication is indicated in combination with lenalidomide followed by monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, autologous stem cell transplant (ASCT). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer MorphoSys Portfolio holder Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Antibody-dependent cell cytotoxicity; CD19 antigen inhibitors Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity New medicine with Priority Medicines (PRIME) ATMP Unknown Submission date June 2020 Expected Registration July 2021 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options De behandeling voor DLBCL bestaat uit chemotherapie in combinatie met een antilichaam tegen CD20. Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation In een fase 2 studie bij patiënten met relapsed/refractory DLBCL na 1-3 eerdere lijnen van behandeling werd een overall response rate gezien van 60%, 42,5% van de patiënten bereikte een complete remissie; deze responsen waren meestal bestendig (mediane responsduur not reached). Dit is een vergelijkbaar percentage als bijvoorbeeld bij CD19 CART cel behandelingen, wat momenteel als de hoogste standaard wordt gezien bij R/R DLBCL. Duration of treatment Frequency of administration 1 times every 2 weeks Dosage per administration 12mg/kg References NCT04150328 https://ashpublications.org/blood/article/134/Supplement_1/1582/427228/Subgroup-Analyses-from-L-Mind-a-Phase-II-Study-of?searchresult=1 Additional remarks Expected patient volume per year Patient volume < 770 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Pakketadvies ibrutinib (Imbruvica®); Raut et al. South Asian J Cancer. 2014 Jan-Mar; 3(1): 66–70; Casulo et al. Blood 2015 125:40-47 Additional remarks In 2016 waren er 1546 patiënten met diffuse large B-cell. Ongeveer 50 tot 60% van de patiënten behalen complete remissie na eerstelijnstherapie. 30 tot 40% relapse en 10% refractory. Het patiëntvolume zal dus maximaal 618 tot 773 patiënten bedragen. Echter worden er beperkte patiëntaantallen verwacht gezien concurrerende geneesmiddelen. 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 Er lopen op dit moment meerdere fase 2 studies. References clinicaltrials.gov Additional remarks Other information Additional remarks