Lifileucel Medicine 08 June 2021 Extended indication Treatment of Patients With Cervical Carcinoma (2L) Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Lifileucel Domain Oncology Reason of inclusion New medicine (specialité) Main indication Cervical cancer Extended indication Treatment of Patients With Cervical Carcinoma (2L) Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Iovance Portfolio holder Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Immunologic cytotoxicity; T lymphocyte replacements Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Yes Submission date 2023 Expected Registration 2024 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 Duration of treatment Frequency of administration Dosage per administration References NCT03108495 Additional remarks Expected patient volume per year Patient volume < 80 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Horizonscan Geneesmiddelen; pembrolizumab + chemo (1L combo) cervical cancer, NKR 2019 incidentie baarmoederhalskanker. Additional remarks Het cervixcarcinoom wordt in Nederland jaarlijks bij ongeveer 912 vrouwen vastgesteld. Er wordt verwacht dat er 70 tot 80 patiënten in aanmerking zullen komen voor eerstelijnsbehandeling met pembrolizumab in combinatie met chemo. Voor de tweede lijn monotherapie cemiplimab komt hierdoor naar verwachting een deel van deze groep in aanmerking. 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 Yes Indication extensions Adenocarcinoma; Breast cancer; Colorectal cancer; Head and neck cancer; Malignant melanoma; Non-small cell lung cancer; Osteosarcoma; Ovarian cancer; Soft tissue sarcoma References Adis Insight Additional remarks Other information Additional remarks