Sacituzumab govitecan Medicine 12 June 2019 Extended indication Relapsed/refractory triple-negative breast cancer (TNBC) Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Sacituzumab govitecan Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Breast cancer Extended indication Relapsed/refractory triple-negative breast cancer (TNBC) Current proprietary name Already available biosimilars / generics Proprietary name TRODELVY Manufacturer Gilead 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 Een antilichaam-geneesmiddel conjugaat bestaande uit een gehumaniseerd antilichaam dat bindt aan TROP-2 en SN-38, een actief metaboliet van irinotecan. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date March 2021 Expected Registration April 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks SPS UK: "Mar 21 · EMA validates MAA for treatment of metastatic triple-negative breast cancer" Therapeutic value Current treatment options Andere middelen die voor deze indicatie geregistreerd worden: atezolizumab en pembrolizumab Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 5.1 month / months Frequency of administration 2 times every 3 weeks Dosage per administration 10 mg/kg References NCT02574455; Bardia et al., N Engl J Med 2019;380:741-51.DOI: 10.1056/NEJMoa1814213. Additional remarks Expected patient volume per year Patient volume 250 - 400 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks In totaal 1.735 diagnoses mammacarcinoom HR-, HER-, waarvan 134 diagnoses stadium 4. Er komen in de loop van de ziekte veel meer patiënten in stadium IV; vergelijkbaar met eerdere inschatting pembrolizumab. Schatting experts: 250-400. Expected cost per patient per year Cost References https://xconomy.com/new-york/2020/04/22/immunomedics-triple-negative-breast-cancer-drug-wins-early-fda-nod/ Additional remarks De Amerikaanse prijs: "Chief Commercial Officer Brendan Delaney said that the price of the drug is $2,012.50 for a single 180 mg vial. How much drug is needed will depend on a patient’s weight and the duration of treatment. But Delaney said that the projected wholesale cost, before discounts and rebates, is between $101,000 and $119,000." 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 Nog geen andere fase 3 studies maar wel in fase 2 onderzocht voor: "urothelial cancer, lung cancer, endometrial cancer, prostate cancer". References Additional remarks Other information Additional remarks