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New Cellular Therapy for Unresectable or Metastatic Melanoma Approved by FDA

  • Post category:Revio News

 Today, from Revio, we are thrilled to share that the U.S. Food and Drug Administration recently approved Amtagvi (lifileucel), the first cellular therapy indicated for the treatment of patients with a type of skin cancer (melanoma) unable to be removed with surgery (unresectable) or that has spread to other parts of the body, and that previously was treated with other therapies. These types are aggressive forms of cancer that can be fatal for the patients, so this approval represents an important milestone in cell immunotherapy.


Melanoma is a form of skin cancer, often caused by exposure to ultraviolet light from sunlight or indoor tanning. Though it represents approximately 1% of all skin cancer cases, it accounts for a significant number of related deaths as it can spread to other parts of the body if not detected and treated early, resulting in metastatic disease.

The treatment of unresectable or metastatic melanoma includes immunotherapy targeting certain proteins in the body to help the immune system fight cancer cells, or drugs targeting specific genes to help manage the growth and functioning of cells.

Amtagvi (Lifileucel)

Amtagvi is a tumor-derived autologous T cell immunotherapy composed of a patient’s own T cells, a type of cell that helps the immune system fight cancer. A portion of the patient’s tumor tissue is removed during a surgical procedure, T cells are then separated from the tumor tissue, and they are manufactured and returned to the same patients as a single dose for infusion. This marks the first FDA-approved tumor-derived T cell immunotherapy.

Clinical trials

The safety and effectiveness of Amtagvi were evaluated in a global, multicenter, multicohort clinical study with adult patients previously treated for unresectable or metastatic melanoma. Among the 73 patients treated, the objective response rate was 31.5%, including three patients with a complete response and 20 patients with a partial response. Among patients who were responsive, 56.5%, 47.8%, and 43.5% continued to maintain responses without tumor progression or death at six, nine, and 12 months respectively.

Despite this, patients treated with Amtagvi may exhibit prolonged severe low blood count, severe infection, cardiac disorder, or develop worsened respiratory or renal function or have fatal treatment-related complications, and a Boxed Warning is included in the label containing information about these risks. Regarding the most common adverse reactions, they include chills, fever, fatigue, tachycardia, diarrhea, febrile neutropenia, edema, rash, hypotension, hair loss, infection, hypoxia, and feeling short of breath.

Expedited Programs

This product was approved through the Accelerated Approval pathway, an expedited program for drugs targeting serious or life-threatening diseases where there is an unmet medical need, and the drug shows potential clinical benefit to patients. This pathway generally gives patients the opportunity for earlier access to a promising therapy while the company conducts confirmatory trials.

Amtagvi also received Orphan Drug, Regenerative Medicine Advanced Therapy, Fast Track, and Priority Review designations. These are available to sponsors of innovative medicines targeting rare or severe conditions that show potential benefit. If you want to learn more about FDA’s expedited programs check our review here! [Insert Link to Review]

If you want to get more information on the approval of Amtagvi you can check the official FDA press release here!

Additionally, we’ve launched a dedicated webpage to bring you the latest updates, guidance, and developments. Follow us on LinkedIn for more.

We hope you find this insightful and interesting. If you would like to discuss any of these updates with the team at REVIO, please get in touch here.