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Paclitaxel trevatide

Extended indication Paclitaxel trevatide monotherapy for first line treatment of newly diagnosed Leptomeningeal disease
Therapeutic value No estimate possible yet
Registration phase Clinical trials

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.
Manufacturer Angiochem
Budgetting framework Intermural (MSZ)
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)
ATMP No
Submission date March 2025
Expected Registration April 2026
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet
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

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

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.