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MDM2-p53 antagonist

Brigimadlin

Extended indication Bij volwassen patiënten met advanced metastatic gedifferentieerd liposarcoom (DDLPS)
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance MDM2-p53 antagonist
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Tumour agnostic medication
Extended indication Bij volwassen patiënten met advanced metastatic gedifferentieerd liposarcoom (DDLPS)
Proprietary name Brigimadlin
Manufacturer Boehringer Ingelheim
Portfolio holder Boehringer Ingelheim
Mechanism of action Receptor antagonist
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks adjuvante therapie

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date October 2024
Expected Registration October 2025
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Current treatment options Doxorubicin
Therapeutic value No estimate possible yet
Substantiation Fase 1a data laten zien dat oraal MDM2-P53 antagonist Brigimadlin een grotere efficacy laat zien in patiënten met DDLPS ten opzichte van SoC. Verdere resultaten worden verwacht in 2026.
Duration of treatment Median 8 month / months
Frequency of administration 1 times a day
Dosage per administration 45mg
References LoRusso et al., The MDM2-p53 Antagonist Brigimadlin (BI 907828) in Patients with Advanced or Metastatic Solid Tumors: Results of a Phase Ia, First-in-Human, Dose-Escalation Study. Cancer Discov. 2023 Aug 4;13(8):1802-1813. doi: 10.1158/2159-8290.CD-23-0153. PMID: 37269344; PMCID: PMC10401071.

Expected patient volume per year

Patient volume

25 - 40

Market share is generally not included unless otherwise stated.
References Orphanet Expert opinions: (Van het totaal aantal patiënten met DDLPS heeft ongeveer de helft van de patiënten Metastatic/advanced DDLPS).

Expected cost per patient per year

Additional remarks De kosten per patiënt per jaar zijn op dit moment nog niet bekend

Potential total cost per year

Additional remarks De totale kosten zijn op dit moment nog niet bekend.

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.