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2-hydroxy Oleic Acid

Extended indication 2-hydroxyoleic acid in combination with radiotherapy and temozolomide for first line treatment of ne
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance 2-hydroxy Oleic Acid
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Brain cancer
Extended indication 2-hydroxyoleic acid in combination with radiotherapy and temozolomide for first line treatment of newly diagnosed primary glioblastoma multiforme in adults and elderly
Manufacturer Laminar
Route of administration Oral
Therapeutical formulation Powder for oral solution
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
ATMP No
Submission date January 2025
Expected Registration February 2026
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Current treatment options Meestal begint de behandeling met een operatie en vervolgens chemoradiatie.
Therapeutic value No estimate possible yet
Substantiation Er is nog geen inschatting mogelijk. Het is een relatief veilig middel. De groep bestaat uit patiënten die in aanmerking komen voor bestraling, als het meerwaarde heeft zal het toegevoegd worden als derde optie binnen de behandellijn. In de recurrent setting werd wel enig effect gezien (1,2).
References Expertopinie (1); Lopez et al. Br J Cancer. 2023 (2).

Expected patient volume per year

Patient volume

< 200

Market share is generally not included unless otherwise stated.
References NKR; Hatanpaa et al. Neoplasia. 2010 Sep; 12(9): 675–684
Additional remarks De incidentie ligt jaarlijks rond de 700 patiënten daarnaast zullen er jaarlijks zeker 100 bij komen na progressie.

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.