Paclitaxel trevatide Medicine 04 June 2024 Extended indication Paclitaxel trevatide monotherapy for first line treatment of newly diagnosed Leptomeningeal disease in HER2-negative breast cancer adults and elderly with brain metastasis previously treated with radiation therapy. Therapeutic value No estimate possible yet Total cost Registration phase No registration expected Product Active substance Paclitaxel trevatide Domain Oncology Reason of inclusion New medicine (specialité) Main indication Brain cancer Extended indication Paclitaxel trevatide monotherapy for first line treatment of newly diagnosed Leptomeningeal disease in HER2-negative breast cancer adults and elderly with brain metastasis previously treated with radiation therapy. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Angiochem Portfolio holder Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks ANG1005 is a paclitaxel-peptide drug conjugate that leverages the low density lipoprotein receptor-related protein 1 (LRP-1) pathway to cross the blood-brain barrier (BBB) and enter cancer cells. Paclitaxel induces programmed cell death (apoptosis) in cancer cells by binding to an apoptosis-stopping protein called Bcl-2 (B-cell leukemia 2), thus arresting its function. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date Expected Registration Orphan drug Yes Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Het bedrijf is permanent gesloten. De website en pijplijn zijn niet beschikbaar en er zijn geen updates over de status van het onderzoek. 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 NCT03613181; https://aacrjournals.org/clincancerres/article/26/12/2789/82516/ANG1005-a-Brain-Penetrating-Peptide-Drug-Conjugate Additional remarks Er zijn nog geen fase 3 resultaten. De resultaten van een eerdere fase II studie waren hoopvol. Het betreft een nieuwe formulering van paclitaxel. Door conjugatie aan angiopep vindt er transport plaats door de BBB via LRP1 receptor. Hierdoor is er lokaal hoge blootstelling. Biologische beschikbaarheid van chemotherapie is een groot probleem bij behandeling van tumoren in het brein. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie Additional remarks Alleen de systemische patiënten die fit zijn voor chemo, zullen in aanmerking komen. Het betreft een zeer kleine groep. 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 Unknown Indication extensions References Additional remarks Other information Additional remarks