Ponatinib Medicine 04 June 2026 Extended indication Treatment of chronic myeloid leukaemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) in adults. Therapeutic value Total cost Registration phase Registration application pending Product Active substance Ponatinib Domain Hematology Reason of inclusion Generic G Main indication CML Extended indication Treatment of chronic myeloid leukaemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) in adults. Current proprietary name Iclusig Already available biosimilars / generics Proprietary name Manufacturer Portfolio holder Mechanism of action Route of administration Therapeutical formulation Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date February 2026 Expected Registration March 2027 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks