2-hydroxy Oleic Acid Medicine 03 December 2024 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 Therapeutic value No estimate possible yet Total cost 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 Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Laminar Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Powder for oral solution Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date January 2025 Expected Registration February 2026 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Meestal begint de behandeling met een operatie en vervolgens chemoradiatie. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. 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). Duration of treatment Frequency of administration Dosage per administration References Expertopinie (1); Lopez et al. Br J Cancer. 2023 (2). Additional remarks Expected patient volume per year Patient volume < 200 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice 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 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