Rivogenlecleucel Medicine 10 June 2020 Extended indication Patients with malignant or non-malignant blood cell disorders who are having a blood stem cell transplant depleted of T cell receptor (TCR) alfa and beta cells that comes from a partially matched family donor. Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Rivogenlecleucel Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Stem cell transplants Extended indication Patients with malignant or non-malignant blood cell disorders who are having a blood stem cell transplant depleted of T cell receptor (TCR) alfa and beta cells that comes from a partially matched family donor. Current proprietary name Already available biosimilars / generics Proprietary name BPX-501 Manufacturer Bellicum Portfolio holder Mechanism of action Allogeneic modified cell therapy Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration 2021 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Dit geneesmiddel is geclassificeerd als een ATMP. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration 10E6 cells/kg References NCT03733249 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 In het EBMT register is te vinden dat er 24 patiënten behandeld zijn met een haploïdentieke donor in 2016 en 20 patiënten in 2017. De verwachting is dat in de periode 2019-2021 een maximum van 25 patiënten behandeld zal worden met een haploïdentieke donor op jaarbasis. Een deel hiervan zal kinderen betreffen. Deze patiënten zullen dus mogelijk in aanmerking komen voor een behandeling. Expected cost per patient per year Cost References Additional remarks De kosten zullen naar verwachting vergelijkbaar zijn met ATIR101. 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 Yes Indication extensions Acute myeloid leukaemia; Myelodysplastic syndromes References adisinsight Additional remarks Other information Additional remarks