Buparlisib

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
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
Manufacturer	Adlai Nortye
Route of administration	Oral
Therapeutical formulation	Tablet
Budgetting framework	Intermural (MSZ)
Additional remarks	PI3K-remmer.

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
Submission date	September 2025
Expected Registration	October 2026
Orphan drug	No
Registration phase	Clinical trials
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.

Current treatment options	Andere immunotherapiën en PD1/PDL1-remmers.
Therapeutic value	No estimate possible yet
Frequency of administration	1 times a day
Dosage per administration	100 mg
References	NCT04338399 (BURAN)

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.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.