Bosutinib Medicine 04 June 2024 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 Total cost Registration phase Registration application pending Product Active substance Bosutinib Domain Hematology Reason of inclusion Indication extension IND 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) Current proprietary name Already available biosimilars / generics Proprietary name Bosulif Manufacturer Pfizer Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Tweede generatie Tyrosinekinaseremmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date March 2024 Expected Registration December 2024 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks NCT04258943 Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks