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Ribociclib

Kisqali

Extended indication Extension of indication to include the adjuvant treatment of adult patients with hormone receptor (H
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 Extension of indication to include the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, Stage II or Stage III early breast cancer, irrespective of nodal status, in combination with an AI for Kisqali.
Proprietary name Kisqali
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 Ribociclib is een selectieve remmer van cycline-afhankelijke kinase (CDK) 4 en 6.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date September 2023
Expected Registration September 2024
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Adjuvant endocrine therapy
Therapeutic value No estimate possible yet
Substantiation Ribiciclib + 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. Disease free survival haalt de PASKWIL criteria voor adjuvante therapie niet. Het is naar verwachting meer toxisch dan huidige behandeloptie.
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

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

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

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.