Trastuzumab deruxtecan

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.
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.

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.

Ribociclib