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Relapsed/refractory triple-negative breast cancer (TNBC)
No judgement
Clinical trials
Sacituzumab govitecan
Oncology and Hematology
New medicine (specialité)
Breast cancer
Immunomedics
Antibody-drug conjugate
Intravenous
Intravenous drip
Intermural (MSZ)
Een antilichaam-geneesmiddel conjugaat bestaande uit een gehumaniseerd antilichaam dat bindt aan TROP-2 en SN-38, een actief metaboliet van irinotecan.
Centralised (EMA)
2021
2022
No
Andere middelen die voor deze indicatie geregisteerd worden: atezolizumab en pembrolizumab
Median 5.1 month / months
2 times every 3 weeks
10 mg/kg
NCT02574455; Bardia et al., N Engl J Med 2019;380:741-51.DOI: 10.1056/NEJMoa1814213.
250 - 400
Market share is generally not included unless otherwise stated.
In totaal 1.687 diagnoses mammacarcinoom HR-, HER-, waarvan 134 diagnoses stadium 4. Er komen in de loop van de ziekte veel meer patienten in stadium IV; vergelijkbaar met eerdere inschatting pembrolizumab. Schatting experts: 250-400.
https://xconomy.com/new-york/2020/04/22/immunomedics-triple-negative-breast-cancer-drug-wins-early-fda-nod/
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."
There is currently nothing known about the possible total cost.
There is currently nothing known about off label use.
Yes
Nog geen andere fase III studies maar wel in fase II onderzocht voor: "urothelial cancer, lung cancer, endometrial cancer, prostate cancer".
There is currently no futher information available.
Understanding of expected market entry of innovative medicines