Pivekimab Sunirine Medicine 03 December 2024 Extended indication Pivekimab sunirine monotherapy for second line or later treatment of relapsed or refractory CD123-positive Blastic plasmacytoid dendritic cell neoplasia in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Pivekimab Sunirine Domain Hematology Reason of inclusion New medicine (specialité) Main indication Myeloproliferative disorders Extended indication Pivekimab sunirine monotherapy for second line or later treatment of relapsed or refractory CD123-positive Blastic plasmacytoid dendritic cell neoplasia in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Abbvie Portfolio holder Abbvie Mechanism of action Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Pivekimab Sunirine is an antibody-drug conjugate (ADC) comprising a high-affinity CD123 antibody, cleavable linker, and an indolinobenzodiazepine pseudodimer (IGN) payload. The IGN payload alkylates DNA and causes single strand breaks without crosslinking. IGNs are designed to have high potency against tumor cells, while demonstrating less toxicity to normal marrow progenitors than other DNA-targeting payloads. Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date September 2026 Expected Registration October 2027 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks FDA goedkeuring ontvangen in mei 2026. 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 NCT03386513 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 Er is nog niets bekend over de mogelijke kosten. 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