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2 Information about lifileucel

Anticipated marketing authorisation indication

2.1

Lifileucel (Amtagvi, Iovance Biotherapeutics) does not have a marketing authorisation in the UK. The anticipated marketing authorisation for lifileucel is for the treatment of adult patients with unresectable or metastatic melanoma (Stage IIIc to Stage IV) previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.

Dosage in the marketing authorisation

2.2

The dosage schedule will be available in the summary of product characteristics for lifileucel.

Price

2.3

The list price of lifileucel is commercial in confidence, so cannot be reported here.

2.4

The company has a commercial arrangement, which would have applied if lifileucel had been recommended.

Carbon Reduction Plan

2.5

Information on the Carbon Reduction Plan for UK carbon emissions for Iovance Biotherapeutics will be included here when guidance is published.