First Cell Therapy for Skin Cancer, Amtagvi, Receives FDA Approval

Iovance Biotherapeutics’ Amtagvi has been approved by the FDA for treating patients with incurable or metastatic melanoma.

On Feb. 16, 2024, FDA announced the approval of Iovance Biotherapeutics’ Amtagvi (lifileucel), which the agency said in a press release is the first cellular therapy indicated for treating adult patients with unresectable or metastatic melanoma that has been previously treated with other therapies (a programmed cell death protein 1-blocking antibody and, if BRAF V600-mutation positive, a BRAF inhibitor with or without a mitogen-activated protein kinase inhibitor).

Amtagvi consists of a patient's T cells derived from a tumor for immunotherapy. It was given the green light through the accelerated approval pathway. Based on clinical research findings, out of the 73 patients who received Amtagvi at the prescribed dosage, 31.5% showed a positive response. This included three patients (4.1%) with a complete response and 20 patients (27.4%) with a partial response. For patients who positively responded to the treatment, the percentages of those who maintained responses without tumor progression or death were 56.5%, 47.8%, and 43.5% at six, nine, and 12 months, as per the FDA press release. An ongoing trial is being conducted to confirm Amtagvi's clinical benefit. Amtagvi has also been granted orphan drug, regenerative medicine advanced therapy, fast track, and priority review designations.

Amtagvi is produced using a special method that gathers and multiplies a patient's specific T cells from a section of their tumor. Approved treatment centers will provide the therapy to patients along with lymphodepletion and a brief high-dose Proleukin (aldesleukin) regimen, as stated in an Iovance company press release.
The therapy will be produced at the Iovance Cell Therapy Center (iCTC) in Philadelphia, Pa. The center can accommodate several thousand patients each year, along with a nearby contract manufacturer. An expansion at the center is currently in progress and is anticipated to greatly boost capacity in the coming years, as mentioned in Iovance's press release.

The iCTC is the first FDA-approved, centralized, and scalable manufacturing facility dedicated to producing tumor-infiltrating lymphocyte cell therapies for patients with solid tumors, according to the company.

Unresectable or metastatic melanoma is a highly aggressive type of cancer that can unfortunately be life-threatening. Amtagvi's approval signifies the result of extensive scientific and clinical research, introducing a new T-cell immunotherapy for patients with few treatment choices.

Approving Amtagvi quickly is the initial move towards fulfilling Iovance's goal of introducing a new era of cell therapy to help patients with advanced solid tumors.

Source: FDA