Sacituzumab govitecan

Active substance
Sacituzumab govitecan
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Breast cancer
Extended indication
Relapsed/refractory triple-negative breast cancer (TNBC)

1. Product

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.

2. Registration

Registration route
Centralised (EMA)
Submission date
2020
Expected Registration
2021
Orphan drug
No
Registration phase
Clinical trials

3. 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.

4. 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.

5. Expected cost per patient per year

There is currently nothing known about the expected cost.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. 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".

9. Other information

There is currently no futher information available.