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 Normal trajectory Particularity ATMP No Submission date July 2026 Expected Registration August 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 Docetaxel monotherapie of docetaxel gecombineerd met een anti-angiogene agent zoals ramucirumab (alleen bij alle histologieën) of nintedanib (alleen bij adenocarcinoom). 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 References NCT05450692 (LATIFY) Additional remarks Expected patient volume per year Patient volume < 2,600 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2022 (1); Qiang X, et al. Transl Oncol. 2025 (2); Sweis et al. Cureus. 2016 (3). Additional remarks In 2022 waren er 10.066 diagnoses NSCLC in Nederland. Dit waren 1.816 patiënten in stadium 1, 868 patiënten in stadium 2, 2247 patiënten in stadium 3, 5135 patiënten in stadium 4. Uitgaande van stadion 3 en 4 komt dat neer op zoʼn 7.382 patiënten. Ongeveer 50% van de stadium 3 en stadium 4 patiënten gaat door voor een tweedelijn therapie. Ongeveer 75% is eligible voor immunotherapie (2). Het zal ongeveer gaan om 2.800 patiënten. Het aantal NSCLC patiënten met EGFR betreft zoʼn 5 tot 10% van deze patiënten. Ongeveer 1,5 tot 4% van de NSCLC patiënten bezit een ALK mutatie. Kortom 6,5 tot 14% heeft één van beide mutaties (3). Als uitgegaan wordt dat 93,5% ALK-/EGFR-negatief is, dan is het patiëntvolume ongeveer 2.600. 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