Ceralasertib Medicine 03 June 2025 Extended indication Ceralasertib in combination with durvalumab for second line or later treatment of locally advanced or metastatic EGFR-negative, ALK-negative Non-small cell lung cancer in adults and elderly whose disease progressed on or after prior anti-PD-(L)1 therapy and platinum-based chemotherapy. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Ceralasertib Domain Oncology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Ceralasertib in combination with durvalumab for second line or later treatment of locally advanced or metastatic EGFR-negative, ALK-negative Non-small cell lung cancer in adults and elderly whose disease progressed on or after prior anti-PD-(L)1 therapy and platinum-based chemotherapy. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer AstraZeneca Portfolio holder AstraZeneca Mechanism of action Other, see general comments Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks An orally available inhibitor of ataxia telangiectasia and rad3 related (ATR) kinase, with potential antineoplastic activity, preventing ATR-mediated signaling, which results in the inhibition of DNA damage checkpoint activation, disruption of DNA damage repair, and the induction of tumor cell death. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date March 2026 Expected Registration April 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Verwachte indieningsdatum is op basis van primary completion datum in augustus 2025. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration NCT05450692 References Additional remarks Expected patient volume per year Patient volume < 3,700 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks In 2021 waren er 10.096 diagnoses NSCLC in Nederland. Dit betrof 1.727 patiënten in stadium I, 822 patiënten in stadium II, 2.231 patiënten in stadium III, 5.247 patiënten in stadium IV. Ongeveer 50% van de stadium III en stadium IV patiënten gaat door voor een tweede lijn therapie. Het zal ongeveer gaan om 3.700 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks