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Lifileucel

Extended indication Treatment of Patients With Cervical Carcinoma (2L)
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Lifileucel
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Cervical cancer
Extended indication Treatment of Patients With Cervical Carcinoma (2L)
Manufacturer Iovance
Mechanism of action Other, see general comments
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Immunologic cytotoxicity; T lymphocyte replacements

Registration

Registration route Centralised (EMA)
ATMP Yes
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet
References NCT03108495

Expected patient volume per year

Patient volume

< 80

Market share is generally not included unless otherwise stated.
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 70-80 patiënten in aanmerking zullen komen voor eerstelijnsbehandeling met pembrolizumab in combinatie met chemo. Voor de tweedelijn monotherapie cemiplimab komt hierdoor naar verwachting een deel van deze groep in aanmerking.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension 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

Other information

There is currently no futher information available.