Ribociclib

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

Therapeutic value	No estimate possible yet
References	NCT03701334

There is currently nothing known about the expected patient volume.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.