Enfortumab vedotin Medicine 06 June 2023 Extended indication Enfortumab vedotin and pembrolizumab in untreated locally advanced or metastatic urothelial cancer. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Enfortumab vedotin Domain Oncology Reason of inclusion Indication extension IND Main indication Bladder cancer Extended indication Enfortumab vedotin and pembrolizumab in untreated locally advanced or metastatic urothelial cancer. Current proprietary name Already available biosimilars / generics Proprietary name PADCEV Manufacturer Astellas Portfolio holder Astellas 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 No Submission date January 2024 Expected Registration October 2024 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Platinum-based chemotherapy or checkpoint inhibitor (PDL-1 positive) Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation het geneesmiddel is geregistreerd voor patiënten in de tweede lijn. Tijdens ESMO 2023 is er een sterk positieve studie gepresenteerd. 33% van de patiënten was nog on treatment ten tijde van analyse, maar geen (mediane) duur van behandeling te destilleren. Het gaat tot verschuiving van eerstelijns behandeling leiden. Duration of treatment Frequency of administration 2 times every 3 weeks Dosage per administration References NCT04223856 Additional remarks Expected patient volume per year Patient volume < 1,213 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2021 (1); Additional remarks In 2021 waren er 754 patiënten met een stadium 3 en 459 patiënten met een stadium 4 carcinoom (1). Dit betekent dat er maximaal 1.213 patiënten in aanmerking zullen komen voor enfortumab vedotin in de eerste lijn. Expected cost per patient per year Cost References medicijnkosten.nl Additional remarks Padcev infusiepoeder flacon 20mg enfortumab vedotine Astellas pharma bv €707,05 per stuk (inclusief BTW) Padcev infusiepoeder flacon 30mg enfortumab vedotine Astellas pharma bv €1.060,57 per stuk (inclusief BTW) 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 MIBC en NMIBC References fabrikant Additional remarks Other information Additional remarks