Iovance Biotherapeutics’ cell therapy Amtagvi received US FDA approval last week, but with a hefty price tag and a manufacturing process that takes 22-days, BioProcess Insider discusses if these factors could affect its rollout.

Millie Nelson, Editor

February 21, 2024

2 Min Read

Last week, the US Food and Drug Administration (FDA) approved Amtagvi (lifileucel), the first one-time cell therapy for patients with advanced melanoma. Amtagvi is a tumor-derived autologous T-cell immunotherapy, which consists of a patient’s own T-cells.

The firm claimed it offers a “new” cell therapy approach using tumor-infiltrating lymphocytes (TILs). The TILs can identify cancer and then the immune system works to create TIL cells to find, fight, and destroy it.

Jason Foster, CEO of Ori Biotech took to LinkedIn and posted NBC News’ article regarding the recent approval. He wrote “the good, the bad, and the ugly on Iovance Biotherapeutics’ new TIL therapy Amtagvi.”

Foster, who’s London-based firm aims to extend patient access for cell and gene therapies (CGTs) through its scalable bioreactor and fluid handling platform, said the “good” related to Amtagvi’s clinical data results, which showed one third of patients had tumors shrink, and for half of these patients this lasted for one year.

The “bad” was attributed to the price tag attached to the therapy, which comes in at $515,000 thousand per patient and as noted by foster, does not include pre-treatment or hospital costs.

And the “ugly” referenced the manufacturing process of Amtagvi. The process of manufacturing TILs takes 22-days. Initially, TIL cells from a patient’s tumor are isolated and then they are expanded by stimulating them ex vivo. The cells are then fragmented in a minimalized cell culture system for the first 11 days before rapid expansion begins. On day 16 the cells are split into multiple flasks, and day 22 they are harvested.

Back in September 2021, the firm opened its Iovance Cell Therapy Center (ICTC) in Philadelphia, US as an opportunity to improve the process further and reduce costs. The therapy will be produced at this facility and the company said it has capacity for up to “several thousand patients annually,” as well as an undisclosed contract manufacturer located nearby. Additionally, Iovance said it is expanding the center to “significantly” up the capacity over the next few years.

Autologous cell therapies have complex manufacturing processes and since the first approval, commercial firms have been aiming to reduce production timelines to lower costs and reach patients more quickly. Recently AstraZeneca cited the importance of platforms that can drastically reduce production times as a driver in its $1.2 billion acquisition of Gracell Biotechnologies.

While the approval can be considered a success from a regulatory viewpoint and the potential for the therapy to be an option to patients, Foster pointed out “with 100 [thousand] patients diagnosed and 8 [thousand] dying per year, the above numbers don’t portend widespread access to Amtagvi for patients nor significant clinical impact beyond the few patients who are lucky enough to receive it.”

He added: “Again, I hope I am wrong but fear I am right.”

About the Author(s)

Millie Nelson

Editor, BioProcess Insider

Journalist covering global biopharmaceutical manufacturing and processing news and host of the Voices of Biotech podcast.

I am currently living and working in London but I grew up in Lincolnshire (UK) and studied in Newcastle (UK).

Got a story? Feel free to email me at [email protected]

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