Expand all sections

Sacituzumab govitecan

Extended indication Relapsed/refractory triple-negative breast cancer (TNBC)
Therapeutic value No judgement
Registration phase Clinical trials

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)
Manufacturer Immunomedics
Mechanism of action Antibody-drug conjugate
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments 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)
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Andere middelen die voor deze indicatie geregisteerd worden: atezolizumab en pembrolizumab
Therapeutic value No judgement
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.

Expected patient volume per year

Patient volume

250 - 400

Market share is generally not included unless otherwise stated.
Additional comments 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.

Expected cost per patient per year

References https://xconomy.com/new-york/2020/04/22/immunomedics-triple-negative-breast-cancer-drug-wins-early-fda-nod/
Additional comments 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

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Nog geen andere fase III studies maar wel in fase II onderzocht voor: "urothelial cancer, lung cancer, endometrial cancer, prostate cancer".

Other information

There is currently no futher information available.