Selpercatinib Medicine 10 June 2020 Extended indication Patients With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer. Therapeutic value Possible added value Total cost Registration phase Registration application pending Product Active substance Selpercatinib Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Patients With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung 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 in de toekomst ook pralsetinib. Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation In de fase 1/2 studie LIBRETTO-001 werd een 68% objective reponse rate geconstateerd en een mediane PFS van 20 maanden zonder noemenswaardige bijwerkingen. De therapeutische meerwaarde ten opzichte van de SoC platina bevattende chemotherapie is daarmee op voorhand groot. De fase 3 data uit de LIBRETTO-431 zullen nog enige tijd op zich laten wachten. Duration of treatment Frequency of administration 2 times a day Dosage per administration References NCT03157128 (LIBRETTO-001) NCT04194944 (LIBRETTO-431); Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References fabrikant; NKR Additional remarks Voor de indicatie longkanker heeft 1-2% van de patiënten een RET-fusie. Uitgaande van 5.000 patiënten met longkanker per jaar bedraagt het verwachte patiëntvolume 50-100 patiënten per jaar. 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 Buiten de indicaties in de horizonscan geen indicatieuitbreidingen bekend. Other information Additional remarks