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Berubicin

Extended indication Berubicin monotherapy for second line treatment of recurrent or progressive IDH mutation-negative gl
Therapeutic value No estimate possible yet
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
Manufacturer Wpd Pharmaceuticals
Mechanism of action Other, see general comments
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
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)
ATMP No
Submission date June 2025
Expected Registration July 2026
Orphan drug No
Registration phase Clinical trials
Additional remarks Indiening op basis van primary completion datum in december 2024.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation De fase II 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.
References NCT04762069

Expected patient volume per year

Patient volume

< 450

Market share is generally not included unless otherwise stated.
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

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.