AMTAGVI lifileucel

Drug Class

Autologous tumor-infiltrating lymphocyte immunotherapy

Mechanism

Consists of patient-derived autologous tumor-infiltrating lymphocytes (TILs) that target and destroy tumor cells presenting specific patient-specific neoantigens.

Approved Indication

Unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody and, if BRAF V600 mutation-positive, a BRAF inhibitor with or without a MEK inhibitor, per its FDA approval.

What This Means For Patients

Amtagvi is a personalized cellular therapy using tumor-infiltrating lymphocytes (TIL) extracted from the patient's own tumor. These immune cells are grown in a lab and infused back to target advanced melanoma that has progressed after chemotherapy or immunotherapy, available in Lecheng.

Regulatory Approvals

• FDA — approved (2024) — source

Pivotal Clinical Evidence

• C-144-01 — Chesney et al., J Immunother Cancer 2022 (NCT02360579) — DOI

Sources

• https://www.fda.gov/news-events/press-announcements/fda-approves-first-cellular-therapy-treat-patients-unresectable-or-metastatic-melanoma
• https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/amtagvi