Durvalumab Medicine 04 December 2025 Extended indication Durvalumab With Stereotactic Body Radiation Therapy (SBRT) vs Placebo With SBRT in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients/ Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation (PACIFIC-4). Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Durvalumab Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Durvalumab With Stereotactic Body Radiation Therapy (SBRT) vs Placebo With SBRT in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients/ Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation (PACIFIC-4). Current proprietary name Already available biosimilars / generics Proprietary name Imfinzi Manufacturer AstraZeneca Portfolio holder AstraZeneca Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Durvalumab-studie met osimertib-arm: een aanvullend cohort zal osimertinib beoordelen na SBRT bij patiënten met niet-gereseceerde T1 tot T3N0M0 NSCLC in een vroeg stadium met een EGFR-mutatie. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date April 2026 Expected Registration March 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Broadly excluded Additional remarks Therapeutic value Current treatment options Stereotactische bestraling (SBRT) Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De studie loopt nog. Duration of treatment Frequency of administration 1 times every 4 weeks Dosage per administration 1500 mg durvalumab References NCT03833154 (PACIFIC-4) Additional remarks Durvalumab 1500 mg, elke 4 weken via een infuus, maximaal 26 keer of totdat de ziekte verergert of er een andere reden is om te stoppen. Expected patient volume per year Patient volume < 1,200 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2022 (1); IKNL (2) Additional remarks Er waren in 2022 in Nederland 1.693 en 823 gevallen van stadium I en II niet-kleincellig longcarcinoom (1). 53% van de patiënten in stadium I (n=897) en 35% van de patiënten in stadium II (n=288) ontvangen radiotherapie. Dit zijn in totaal 1.185 patiënten. 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks