New York-based Iovance Biotherapeutics has received FDA approval for its skin cancer therapy, Amtagvi (Lifileucel), specifically designed to treat adult patients with difficult-to-remove or metastatic melanoma. The one-time treatment is priced at USD 515,000 per patient.

Amtagvi is a cell therapy treatment that utilizes a patient's T-cells extracted from their tumor tissue. The treatment is reportedly the first one-time cell therapy for a solid tumor and the first tumor-infiltrating lymphocytes (TIL) therapy approved by the FDA.

Iovance Biotherapeutics is engaged in developing TIL therapies targeted at treating cancer. The company's investigational TIL therapies are designed to boost a patient's natural immune cells to target and eliminate cancer. The company has 20 programs in its immuno-oncology pipeline, of which 10 are in Phase II, and four are in the pivotal stage.

Analyst QuickTake : Amtagvi kickstarts 2024’s cell and gene therapy (CGT) approvals and joins the line of cell and gene therapies approved by the FDA within the last couple of months, making major strides in the industry. Other recent approvals include Bluebird Bio’s gene therapy Lyfgenia for sickle cell disease, Sarepta’s gene therapy Elevidys for Duchenne muscular dystrophy (DMD), and Krystal Biotech’s gene therapy Vyjuvek for dystrophic epidermolysis bullosa (DEB) wounds. Several CGTs are expected to receive approval this year including Autolus Therapeutics’s CAR-T therapy autoleucel (obe-cel) pending decision in November .