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Dostarlimab

Extended indication Monotherapy in women with advanced or recurrent MSI-H and MSS endometrial cancer who progressed on o
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Dostarlimab
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Oncology other
Extended indication Monotherapy in women with advanced or recurrent MSI-H and MSS endometrial cancer who progressed on or after a platinum-based regimen.
Manufacturer GSK
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Submission date April 2020
Expected Registration April 2021
Orphan drug No
Registration phase Registration application pending
Additional remarks De fabrikant verwacht indiening in de eerste helft van 2020 en registratie in de eerste helft van 2021.

Therapeutic value

Current treatment options In de tweede lijn wordt voor immunotherapie bjivoorbeeld Megestrol of Medroxyproges-teron acetaat (MPA) toegedient.
Therapeutic value No judgement
Frequency of administration 1 times every 3 weeks
Dosage per administration 500 mg tot 1000 mg
References NCT02715284
Additional remarks 500mg per 3 weken voor de eerste 4 cycles gevolgd door 1.000mg iedere 6 weken. De fabrikant geeft aan dat de GARNET studie een fase 1/2 studie is.

Expected patient volume per year

Patient volume

18 - 35

Market share is generally not included unless otherwise stated.
References NKR; Follow-up after primary therapy for endometrial cancer: a systematic review. Fung-Kee-Fung. Gynecol Oncol. 2006 Jun;101(3):520-9. Epub 2006 Mar 23.; Sorbe B, Juresta C, Ahlin C. Natural history of recurrences in endometrial carcinoma. Oncol Lett. 2014;8(4):1800–1806. doi:10.3892/ol.2014.2362
Additional remarks Er waren in 2015 in totaal 1.931 patiënten met een endometriumcarcinoom. Daarvan betrof het in 177 gevallen een carcinoom van stadium 4. De recurrence rate voor endometrium carcinoom bedraagt ongeveer 10 tot 20%. Dit zou betekenen dat 18 tot 35 patiënten mogelijk in aanmerking komen voor deze behandeling.

Expected cost per patient per year

There is currently nothing known about the expected cost.

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 Fallopiantube, ovarian and peritoneal cancer.
References clinicaltrials.gov
Additional remarks Op dit moment lopen er meerdere fase 3 studies naar boven genoemde indicaties.

Other information

There is currently no futher information available.