Neladalkib Medicine 03 June 2025 Extended indication Neladalkib monotherapy for second line or later treatment of locally advanced or metastatic ALK-positive Non-small cell lung cancer in adults and elderly who have received prior ALK tyrosine kinase inhibitors. Therapeutic value Possible added value Total cost Registration phase Clinical trials Product Active substance Neladalkib Domain Oncology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Neladalkib monotherapy for second line or later treatment of locally advanced or metastatic ALK-positive Non-small cell lung cancer in adults and elderly who have received prior ALK tyrosine kinase inhibitors. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Nuvalent Portfolio holder Mechanism of action Other, see general comments Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks NVL-655 is een hersendoordringende ALK-selectieve remmer. Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date June 2026 Expected Registration June 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Lorlatinib Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation De objective response rate was 80% en het heeft een gunstig bijwerkingenprofiel (2). Waarschijnlijk is neladalkib minder toxisch dan lorlatinib (3). Duration of treatment Frequency of administration Dosage per administration References NCT05384626 (ALKOVE-1) (1); ESMO 2024 (2); Expertopinie (3). Additional remarks Expected patient volume per year Patient volume < 105 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie (1); Declaratiedata (2) Additional remarks Het is mogelijk dat dit lorlatinib gaat vervangen (1). In 2023 waren er 105 gebruikers van lorlatinib (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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks