Pembrolizumab / favezelimab Medicine 05 December 2023 Extended indication Patients With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Pembrolizumab / favezelimab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Colon cancer Extended indication Patients With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer MSD Portfolio holder MSD Mechanism of action Combination therapy Route of administration Intravenous Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Co-formulation of PD-1 inhibitor and LAG-3 inhibitor Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity New therapeutical formulation ATMP No Submission date 2025 Expected Registration 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options TAS-102 Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn nog geen resultaten. De studie loopt tot augustus 2024. Duration of treatment Maximal 2 year / years Frequency of administration 1 times every 3 weeks Dosage per administration favezelimab/pembrolizumab 800mg/200mg References NCT05064059 Additional remarks Bispecifiek antilichaam tegen PD-L1 en LAG3 en stimuleert tumorcel afbraak T-cellen via dendritische cel-activatie. De Fase 3 studie loopt nog. Fase 1 laten geringe respons zien en te managen toxiciteit. Expected patient volume per year Patient volume 500 - 550 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2021 (1); Expertopinie (2). Additional remarks Gemetastaseerde coloncarcinoom betreft 2.085 patiënten in stadium 4 (1). Bij een positief resultaat komt een selectie van de patiënten die momenteel behandeld worden met regorafenib of TAS102 in aanmerking voor favelimab/pembrolizumab (2). 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