Nemtabrutinib Medicine 04 December 2025 Extended indication Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Nemtabrutinib Domain Hematology Reason of inclusion New medicine (specialité) Main indication CLL Extended indication Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer MSD Portfolio holder MSD Mechanism of action Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date 2026 Expected Registration 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Pirtobrutinib Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er loopt op dit moment een fase 3 studie. Er is ook een fase 1 studie gedaan met patiënten die al btk-remmers hebben gehad. De verwachting is dat de therapeutische waarde vergelijkbaar zal zijn met pirtobrutinib. Duration of treatment Frequency of administration 1 times a day Dosage per administration 65mg References NCT05624554 (BELLWAVE-008) Additional remarks Expected patient volume per year Patient volume 70 - 110 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References CMyLife. 2025 (1); Griffin et al. Blood Adv. 2023 (2). Additional remarks In 2024 kregen 1.025 mensen de diagnose chronische lymfatische leukemie (CLL) (1). Voor SLL (small lymphocytic lymphoma) worden geen aparte cijfers gerapporteerd, omdat dit biologisch dezelfde ziekte is als CLL, alleen met een andere presentatie. Het aantal nieuwe SLL-patiënten zit dus in deze groep. De prevalentie van TP53-mutaties varieert van 7% tot 11% bij onbehandelde CLL (2). 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