Bosutinib

Extended indication	Extension of indication to include treatment of paediatric patients greater than or equal to 1 year of age with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML)
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Bosutinib
Domain	Hematology
Reason of inclusion	Indication extension
Main indication	CML
Extended indication	Extension of indication to include treatment of paediatric patients greater than or equal to 1 year of age with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML)
Proprietary name	Bosulif
Manufacturer	Pfizer
Route of administration	Oral
Therapeutical formulation	Tablet
Budgetting framework	Intermural (MSZ)
Additional remarks	Tweede generatie Tyrosinekinaseremmer

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
Submission date	March 2024
Expected Registration	December 2024
Orphan drug	No
Registration phase	Registration application pending
Additional remarks	NCT04258943

Therapeutic value	No estimate possible yet

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.