Skip to content

On this page

Amtagvi

Lifileucel

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Amtagvi

Proper name

Lifileucel

Licence type

351(a)

BLA number

125773

Applicant

Iovance Biotherapeutics, Inc.

Center

CBER

Presentations

1

First licensure

February 16, 2024

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
7.5x10^9 to 72x10^9Cells	Suspension	Intravenous	Bag	Rx	February 16, 2024

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	February 16, 1931

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity