Buparlisib Medicine 03 December 2024 Extended indication Buparlisib in combination with paclitaxel for second line or later treatment of refractory, recurrent, or metastatic squamous cell carcinoma of head and neck in adults and elderly after treatment with PDL1/PD1-based therapy Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Buparlisib Domain Oncology Reason of inclusion New medicine (specialité) Main indication Head and neck cancer Extended indication Buparlisib in combination with paclitaxel for second line or later treatment of refractory, recurrent, or metastatic squamous cell carcinoma of head and neck in adults and elderly after treatment with PDL1/PD1-based therapy Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Adlai Nortye Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks PI3K-remmer. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date September 2025 Expected Registration October 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Gebaseerd op de primary completion datum in juni 2025, kan een indieningsdatum in september 2025 en een verwachte registratie in oktober 2026 geschat worden. Therapeutic value Current treatment options Andere immunotherapiën en PD1/PDL1-remmers. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 100 mg References NCT04338399 (BURAN) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2021 (1). Additional remarks In 2021 werden er 8.943 patiënten met plaveiselcelcarcinoom van de huid van hoofd en hals gediagnosticeerd, waarvan 149 stadium III en IV (1). Gezien dit een tweedelijnsbehandeling is zal het verwachte patiëntvolume lager liggen. 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