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.