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Ribociclib

Extended indication Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/​HER2- Early Breast Cancer
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Ribociclib
Domain Oncology
Reason of inclusion Indication extension
Main indication Breast cancer
Extended indication Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/​HER2- Early Breast Cancer
Manufacturer Novartis
Portfolio holder Novartis
Mechanism of action CDK4 / 6 tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks Exact indication not yet known

Registration

Registration route Centralised (EMA)
ATMP No
Submission date July 2023
Expected Registration May 2024
Registration phase Registration application pending

Therapeutic value

Current treatment options Adjuvant endocrine therapy
Therapeutic value No estimate possible yet
Substantiation RIB + ET liet een significant langere iDFS dan enkel ET zien (HR, 0.748; 95% CI, 0.618-0.906; P = .0014). Er is nog geen overlevingswinst aangetoond
Duration of treatment Average 3 year / years
Frequency of administration 1 times a day
Dosage per administration 400 mg
References https://clinicaltrials.gov/study/NCT03701334?term=NATALEE&intr=ribociclib&aggFilters=phase:3&rank=1
Additional remarks Awaiting publication of study results

Expected patient volume per year

Patient volume

< 2,338

Market share is generally not included unless otherwise stated.
References IKNL: Ned Kanker registratie 2018 en waar mogelijk is een gemiddelde genomen van de jaren 2018 + 2019.
Additional remarks Incidentie invasief mammacarcinoom is 14.845. Totaal aantal invasieve HR+, HER2- vroeg stadium borstkankerpatiënten (na selectie op minstens 1 positieve lymfeklier, zonder micrometastasen. En exclusie van stadium 0 en 4 patiënten (en reeds chirurgie ondergaan) is 2.338.

Expected cost per patient per year

Additional remarks Er is een financieel arrangement van toepassing tot 1 januari 2025.

Potential total cost per year

Additional remarks Unknown, awaiting EMA label

Off label use

Off label use No

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.