Extended indication

For adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have rec

Therapeutic value

Possible added value

Total cost

31,758,187.50

Registration phase

Positive CHMP opinion

Product

Active substance

Sacituzumab govitecan

Domain

Oncology and Hematology

Reason of inclusion

New medicine (specialité)

Main indication

Breast cancer

Extended indication

For adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for advanced disease

Proprietary name

TRODELVY

Manufacturer

Gilead

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)

Type of trajectory

Accelerated assessment

Submission date

March 2021

Expected Registration

December 2021

Orphan drug

No

Registration phase

Positive CHMP opinion

Additional comments
SPS United Kingdom: "March 2021 · EMA validates MAA for treatment of metastatic triple-negative breast cancer". 
Positieve CHMP opinie ontvangen oktober 2021.

Therapeutic value

Current treatment options

Andere middelen die voor deze indicatie geregistreerd worden: atezolizumab en pembrolizumab

Therapeutic value

Possible added value

Substantiation

De verwachting is dat de PAKSWIL-criteria gehaald zullen worden. In de studie kregen in totaal 468 patiënten sacituzumab govitecan (235 patiënten) of chemotherapie (233 patiënten). De mediane progressie-vrije survival was 5,6 maanden (95% confidence interval [CI], 4.3 to 6.3; 166 events) met sacituzumab govitecan and 1,7 maanden (95% CI, 1.5 to 2.6; 150 events) met chemotherapie (hazard ratio for disease progression or death, 0.41; 95% CI, 0.32 to 0.52; P<0.001). De mediane overall survival was 12,1 maanden (95% CI, 10.7 to 14.0) met sacituzumab govitecan en 6,7 maanden (95% CI, 5.8 to 7.7) met chemotherapie (hazard ratio for death, 0.48; 95% CI, 0.38 to 0.59; P<0.001).

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 comments
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

Cost

90,000.00 - 105,435.00

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 180mg 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." omgekrened is dit €90.000 tot €105.435. De prijs in Nederland is nog niet bekend.

Potential total cost per year

Total cost

31,758,187.50

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

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.