Extended indication Extension of indication to include lenvatinib in combination with pembrolizumab for the treatment of
Therapeutic value No estimate possible yet
Total cost 1,233,000.00
Registration phase Registration application pending

Product

Active substance Lenvatinib
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Other oncology
Extended indication Extension of indication to include lenvatinib in combination with pembrolizumab for the treatment of adult patients with advanced endometrial carcinoma (EC) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation; as a consequence.
Proprietary name Lenvima
Manufacturer Eisai
Mechanism of action Other, see general comments
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional comments Receptortyrosinekinase inhibitor van VEGFR1, 2 en 3, FGFR1, 2, 3 en 4 en PDGFRα, KIT en RET

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date March 2021
Expected Registration November 2021
Orphan drug No
Registration phase Registration application pending
Additional comments Fabrikant verwacht registratie in november 2021.

Therapeutic value

Current treatment options Chemotherapie
Therapeutic value No estimate possible yet
Substantiation Het komt naar waarschijnlijkheid overeen met dostarlimab. Meerdere geneesmiddelen voor eenzelfde kleine indicatie. Mogelijk verdringt het en/of substitutie van dostarlimab.
Duration of treatment Median 231 day / days
Frequency of administration 1 times a day
Dosage per administration 20mg
References "Makker V et al., SGO Virtual Annual Meeting On Women's Cancer 2021, abstract id 11512. https://157slyoyo4y17zpa538hczs1-wpengine.netdna-ssl.com/wp-content/uploads/2021/01/FRIDAY_2021-Virtual-Annual-Meeting-on-Womens-Cancer.pdf Studie: E7080-G000-309 / KEYNOTE-775 (NCT03517449)"
Additional comments 20mg (= maximum startdosering. Dosis reductie stappen 14mg, 10mg, 8mg)

Expected patient volume per year

Patient volume

40 - 50

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 comments Er waren in 2018 in totaal 1.903. De recurrence rate voor endometrium carcinoom bedraagt ongeveer 10%-20%. Er wordt verwacht dat er 40 tot 50 patiënten in aanmerking zullen komen voor deze behandeling.

Expected cost per patient per year

Cost 27,400.00
References G-standaard
Additional comments AIP per april 2021: €1.780,12 verpakking á 30 capsules (4mg of 10mg). Uitgaande van een behandeling van maximaal 20mg/dag (= max. 2 capsules) voor 231 dagen zou dat gaan om maximaal €27.400 per patiënt per jaar

Potential total cost per year

Total cost

1,233,000.00

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Weergegeven in de Horizonscan Geneesmiddelen.
References Fabrikant

Other information

There is currently no futher information available.