Sonrotoclax Medicine 04 December 2025 Extended indication Sonrotoclax monotherapy for second line or later treatment of relapsed or refractory mantle cell lymphoma in adults and elderly previously treated with a Bruton’s tyrosine kinase inhibitor (BTKi) and anti-CD20 based immune or chemoimmunotherapy. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Sonrotoclax Domain Hematology Reason of inclusion New medicine (specialité) Main indication Aggressive non-Hodgkin’s lymphoma Extended indication Sonrotoclax monotherapy for second line or later treatment of relapsed or refractory mantle cell lymphoma in adults and elderly previously treated with a Bruton’s tyrosine kinase inhibitor (BTKi) and anti-CD20 based immune or chemoimmunotherapy. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer BeOne Portfolio holder BeOne Mechanism of action Bcl-2 inhibitor Route of administration Oral Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP Submission date November 2025 Expected Registration December 2026 Orphan drug Registration phase Clinical trials 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 NCT05471843 (BGB-11417-201) 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