Zanubrutinib Medicine 06 June 2023 Extended indication Extension of indication to include in combination with obinutuzumab treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic treatments. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Zanubrutinib Domain Hematology Reason of inclusion Indication extension IND Main indication Indolent non-Hodgkin’s lymphoma Extended indication Extension of indication to include in combination with obinutuzumab treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic treatments. Current proprietary name Already available biosimilars / generics Proprietary name Brukinsa Manufacturer Astex Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date March 2023 Expected Registration January 2024 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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