‘Landmark Approval’ Brings New Weapon to Advanced Melanoma Fight

The FDA recently approved a first-in-class agent to treat a particularly deadly cancer. The therapy signifies a promising new development in the treatment of solid tumors, which represent about 90% of all cancers in the U.S.

On Feb. 16, the FDA gave accelerated approval to Iovance Biotherapeutics, Inc.’s Amtagvi (lifileucel) for the treatment of adults with unresectable or metastatic melanoma previously treated with a programmed death receptor-1 (PD-1) inhibitor and, if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor. The agency gave the therapy orphan drug, regenerative medicine advanced therapy, fast track and priority review designations.

The tumor infiltrating lymphocyte (TIL) therapy, which is created from a patient’s unique T cells from their tumor, is the first and only one-time individualized T cell therapy with FDA approval for a solid tumor cancer. Doctors remove a portion of a patient’s tumor and then separate the TIL cells — which locate, attack and destroy cancer — from the tumor tissue, replicate them and then return them to that patient via an intravenous infusion.

More than 30 authorized treatment centers are available to collect and ship tumor tissue, which is sent to Iovance’s Philadelphia Iovance Cell Therapy Center for manufacturing and then returned to an ATC for administration. The cost of a one-time infusion is $515,000.

According to the American Cancer Society, melanoma accounts for only about 1% of skin cancers, and it is expected to kill more than 8,200 people in the U.S. in 2024.

Amtagvi is the first FDA-approved treatment for people with advanced melanoma whose disease progressed after initial treatment with an immune checkpoint inhibitor and, if appropriate, targeted therapy.

“This landmark FDA approval reflects significant advancements in TIL cell therapy since we initially showed that TIL cells isolated from patients with metastatic melanoma could be expanded in the lab and returned to the patient to mediate cancer regression,” said Steven Rosenberg, M.D., Ph.D., chief of the surgery branch at the National Cancer Institute, and a TIL and immunotherapy pioneer. “This approval is transformative for the entire research field and supports continued investigation of TIL cell therapy across additional types of solid tumors.”

For the Managed Care Oncology Index: Q1 2023, from March 2, 2023, to March 28, 2023, Zitter Insights polled 35 commercial payers covering 117.9 million lives, 25 Medicare payers covering 40.2 million lives, 50 oncologists and 50 practice managers about their management of and prescribing for metastatic melanoma. Almost half of payers said they rate managing brand treatments for the condition an average priority. Payers with 59% of covered commercial lives said they are somewhat aggressive in their management of branded agents, meaning that they cover all agents, but some may be preferred over others through the use of tiering, step edits and/or prior authorization.

Two-thirds of payers expressed average satisfaction with current metastatic melanoma treatments. Payers representing 90% of commercial lives and 84% of Medicare lives said there is a high or very high unmet need in treating metastatic melanoma (see chart).

For more information on the Zitter Insights data, contact Jill Brown Kettler at jkettler@mmitnetwork.com.