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Sacituzumab govitecan

Medicine

Extended indication Trodelvy is indicated as monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cance
Registration phase Positive CHMP opinion

Product

Active substance Sacituzumab govitecan
Domain Oncology
Reason of inclusion Indication extension IND
Main indication Breast cancer
Extended indication Trodelvy is indicated as monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy
Proprietary name Trodelvy
Manufacturer Gilead
Portfolio holder Gilead
Mechanism of action Other, see general comments
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Trop-2 directed antibody-drug conjugate

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Indication extension
ATMP No
Submission date January 2026
Expected Registration July 2026
Orphan drug No
Registration phase Positive CHMP opinion
Medicine sluice Broadly excluded
Additional remarks Positieve CHMP-opinie in mei 2026.

Therapeutic value

Substantiation De combinatie sacituzumab govitecan + pembrolizumab verbeterde de mediane progressievrije overleving (PFS) tot 11,2 maanden, vergeleken met 7,8 maanden met chemotherapie + pembrolizumab (HR 0,65). De overall‑survivaldata zijn nog onvolwassen. De objectieve respons bedroeg 60% tegenover 53%, en de duur van respons was duidelijk langer met sacituzumab govitecan + pembrolizumab (16,5 vs. 9,2 maanden).
Frequency of administration 2 times every 3 weeks
Dosage per administration 10 mg/kg
References NCT05382286
Additional remarks 10 mg/kg on Days 1 and 8 of 21-day cycles.

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.
References 1: NKR2022; 2: The Prevalence of PD-L1 Expression in Triple-Negative Breast Cancer Patients and Its Correlation with Survival Rates and Other Prognostic Factors: A Survival Analysis. Izadi et al, 2024.
Additional remarks Het totaal aantal vrouwen met invasieve borstkanker in Nederland is ongeveer 17.900 per jaar. Ongeveer 10% van de gevallen betreft triple negatieve borstkanker (1). 77% van de triple negatieve borstkanker patiënten hebben PD-L1 expressie (2).

Expected cost per patient per year

Cost € < 68,700.00

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.
References Pakketadvies sluisgeneesmiddel sacituzumab govitecan (Trodelvy®) voor de behandeling van inoperabele of uitgezaaide borstkanker, ZIN 2022
Additional remarks In de budget impact analyse van 2022 wordt de prijs per patiënt per jaar geraamd op €68.706,76. Dit middel is in de sluis geplaatst tot er een financieel arrangement is overeengekomen.

Potential total cost per year

Off label use

Indication extension

Other information