Bgb-16673 Medicine 04 June 2026 Extended indication Second line treatment of relapsed or refractory Chronic lymphocytic leukaemia in adults and elderly previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i). Therapeutic value Total cost Registration phase Clinical trials Product Active substance Bgb-16673 Domain Hematology Reason of inclusion New medicine (specialité) Main indication CLL Extended indication Second line treatment of relapsed or refractory Chronic lymphocytic leukaemia in adults and elderly previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer BeOne Portfolio holder BeOne Mechanism of action Other, see general comments Route of administration Oral Therapeutical formulation Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Werkingsmechanisme: Proteolyse-gerichte chimera (PROTAC) voor Brutonʼs tyrosinekinase (BTK). Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP Submission date June 2026 Expected Registration July 2027 Orphan drug Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options BTK inhibitors, BCL2 inhibitors, anti-CD20 monoclonal antibodies. Therapeutic value Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT05006716 (fase 1/2), NCT06846671 (fase 3; BGB-16673-302) Additional remarks Expected patient volume per year Patient volume < 325 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References (1) NKR (2) Farmacotherapeutisch rapport ibrutinib (Imbruvica®) voor de behandeling van volwassen patiënten met chronische lymfatische leukemie (CLL) die niet eerder zijn behandeld. Additional remarks Volgens NKR was de incidentie van personen met CLL 1.219 patiënten in het jaar 2025 (1). Ieder jaar starten ongeveer 600 à 700 patiënten met een behandeling tegen CLL (2). Ongeveer een derde van de nieuwe patiënten wordt dus nooit behandeld. Expected cost per patient per year Cost References Additional remarks Er is nog niets bekend over de mogelijke prijs. 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