Sigovatug vedotin Medicine 04 December 2025 Extended indication Treatment of patients with previously treated locally advanced, unresectable, or metastatic nonsquamous non-small cell lung cancer (NSCLC). Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Sigovatug vedotin Domain Oncology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Treatment of patients with previously treated locally advanced, unresectable, or metastatic nonsquamous non-small cell lung cancer (NSCLC). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Pfizer Portfolio holder Pfizer Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Powder for solution for infusion Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Sigovatug vedotin is an antibody-drug conjugate composed of 3 components: a monoclonal antibody directed to IB6 (integrin beta-6), a microtubule-disrupting agent MMAE (monomethyl auristatin E), and a protease-cleavable mc-vc (maleimidocaproyl-valine-citrulline) linker that covalently attaches MMAE to the antibody, which enables preferential release of MMAE within target cells. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date July 2026 Expected Registration October 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In de Be6A Lung-01 fase 3 studie wordt sigvotatug vedotin vergeleken met docetaxel. Er zijn nog geen resultaten bekend. Duration of treatment Frequency of administration 2 times every 4 weeks Dosage per administration Op dag 1 en dag 15 van een 28 daagse cyclus. 1,8mg per kg. Aangepast aan ideaal lichaamsgewicht References NCT06012435 (Be6A Lung-01) Additional remarks Expected patient volume per year Patient volume < 6,595 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 1: NKR2022; 2: A population-based study describing characteristics, survival and the effect of TKI treatment on patients with EGFR mutated stage IV NSCLC in the Netherlands. Deirdre M.H.J. ten Berge. 2022; 3: Langereis RF et al., 2021 – “Real-world treatment patterns and survival outcomes for stage III NSCLC: Dutch population-based data.” Additional remarks In 2022 waren er 2.247 patiënten met NSCLC stadium III. Hiervan is 60 tot 70% stadium 3 is niet resectabel (2). Er waren 5.135 patiënten met stadium IV .Ongeveer 82% van deze patiënten heeft een niet-plaveiselcelcarcinoom (3)(6.053). Expected cost per patient per year Cost References Additional remarks De prijs is nog niet vastgesteld. De prijsstelling zal niet vóór het eerste kwartaal van 2028 beschikbaar zijn Potential total cost per year Total cost Total cost for sluice Additional remarks Er is op dit moment niets bekend over de verwachte kosten. Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks