Selpercatinib Medicine 10 June 2020 Extended indication Patients With RET-Mutant Medullary Thyroid Cancer Therapeutic value No judgement Total cost Registration phase Registration application pending Product Active substance Selpercatinib Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Thyroid cancer Extended indication Patients With RET-Mutant Medullary Thyroid Cancer Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Eli Lilly Portfolio holder Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Tyrosine kinase inhibitor met antineoplastische eigenschappen. Potente, selectieve remmer van de RET-kinase, ontwikkeld om de ATP-bindingsite vd RET-kinase te blokkeren. Zo wordt de ‘down stream’ signalling pathway geremd. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date February 2020 Expected Registration March 2021 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options RET fusie-positieve NSCLC: Carboplatin/Cisplatin + Pemetrexed +/- Pembrolizumab.RET-gemuteerde medullaire thyroïd kanker: Cabozantinib/vandetanib Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 2 times a day Dosage per administration References NCT04211337 (LIBRETTO-531) 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 No Indication extensions References adisinsight Additional remarks Other information Additional remarks