Berubicin Medicine 03 December 2024 Extended indication Berubicin monotherapy for second line treatment of recurrent or progressive IDH mutation-negative glioblastoma multiforme in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Berubicin Domain Oncology Reason of inclusion New medicine (specialité) Main indication Brain cancer Extended indication Berubicin monotherapy for second line treatment of recurrent or progressive IDH mutation-negative glioblastoma multiforme in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Wpd Pharmaceuticals Portfolio holder Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Berubicin is one of the first anthracyclines that crosses the blood brain barrier and overcomes drug resistance. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date June 2025 Expected Registration July 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Indiening op basis van primary completion datum in december 2024. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De fase 2 studie in vergelijking met lomustine loopt nog bij recidief GBM. Dit middel wordt waarschijnlijk ingezet bij een kleine groep patiënten met een zeer agressieve tumor. Duration of treatment Frequency of administration Dosage per administration References NCT04762069 Additional remarks Expected patient volume per year Patient volume < 450 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie Additional remarks In Nederland zijn er jaarlijks ongeveer 1.100 patiënten met de diagnose glioma waarbij er ongeveer 800 de diagnose glioblastoma krijgen. Hiervan worden er tussen de 60 tot 70% primair behandeld met chemoradiatie. Meer dan 90% van de glioblastoma's zijn recurrent. Ongeveer 90% zijn IDH wild type. Er zullen dus maximaal 450 patiënten mogelijk in aanmerking komen voor deze behandeling. 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