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 Registered

Product

Active substance Sacituzumab govitecan
Domain Oncology
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
ATMP No
Submission date March 2021
Expected Registration November 2021
Orphan drug No
Registration phase Registered
Additional comments SPS United Kingdom: "March 2021 · EMA validates MAA for treatment of metastatic triple-negative breast cancer". Positieve CHMP opinie ontvangen oktober 2021. Aangezien het verwachte macrokostenbeslag meer dan € 40 miljoen per jaar is voor Sacituzumab govitecan is de verstrekking van het geneesmiddel breed in de sluis geplaatst voor de behandeling van kanker.

Therapeutic value

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 4.4 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 2021; 384:1529-1541- DOI: 10.1056/NEJMoa2028485

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" omgerekend is dit €90.000 tot €105.435. De prijs in Nederland is nog niet bekend. Dit middel is in de sluis geplaatst tot er een financieel arrangement is overeengekomen.

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 Momenteel loopt de fase 3 registratiestudie voor de behandeling van patiënten met hormoonreceptor-positieve (HR+), humane epidermale groeifactorreceptor 2-negative (HER2-), gemetastaseerde borstkanker
References NCT03901339

Other information

There is currently no futher information available.