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MDM2-p53 antagonist

Brigimadlin

Extended indication

Bij volwassen patiënten met advanced metastatic gedediferntieerd 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 gedediferntieerd 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

June 2024
Expected Registration

June 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.