Trastuzumab deruxtecan Medicine 08 December 2020 Extended indication Extension of indication to include monotherapy treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior anti-HER2-based regimen Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Trastuzumab deruxtecan Domain Oncology Reason of inclusion Indication extension IND Main indication Stomach cancer Extended indication Extension of indication to include monotherapy treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior anti-HER2-based regimen Current proprietary name Already available biosimilars / generics Proprietary name Enhertu Manufacturer AstraZeneca Portfolio holder Mechanism of action Antibody-drug conjugate Route of administration Intravenous Therapeutical formulation Injection / infusion solution Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date October 2021 Expected Registration August 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks De fabrikant verwacht registratie in de tweede helft van 2022. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Op dit moment loopt de DESTINY-Gastric02 studie nog. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 6,4mg/kg References Additional remarks Expected patient volume per year Patient volume < 78 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL; expertopinie; Record rivoceranib Additional remarks Ongeveer 70 patiënten worden behandeld in de tweede lijn voor gemetastaseerd adenocarcinoom van de maag of gastro-oesofageale overgang. Het aantal patiënten met een slokdarmcarcinoom die in de tweede lijn worden behandeld bedraagt ongeveer 60. In totaal zijn dit dus 130 patiënten. De inschatting is dat hiervan maximaal 60% een derdelijns behandeling krijgt (78 patiënten). Expected cost per patient per year Cost References https://www.fiercepharma.com/special-report/1-enhertu Additional remarks De verwachte prijs in de Verenigde Staten: $13,300 per maand. De prijs in Nederland is nog niet bepaald. 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 Treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti HER2 based regimens (NCT03248492). Treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2 therapies (2L) (NCT03529110). Treatment of adult patients with unresectable or metastatic HER2-Low breast cancer. Treatment of adult patients with HER2-mutated, Unresectable and/or Metastatic non-small cell lung cancer (NSCLC) (NCT03505710). References Additional remarks Other information Additional remarks