Extended indication Relapsed/refractory triple-negative breast cancer (TNBC)
Therapeutic value No estimate possible yet
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)
Proprietary name TRODELVY
Manufacturer Gilead
Mechanism of action Antibody-drug conjugate
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
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
Submission date March 2021
Expected Registration April 2022
Orphan drug No
Registration phase Registration application pending
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
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.

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

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

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 3 studies maar wel in fase 2 onderzocht voor: "urothelial cancer, lung cancer, endometrial cancer, prostate cancer".

Other information

There is currently no futher information available.