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FDA Approves Yet Another Cell Tx – Amtagvi

The FDA recently approved yet another – first in class -cellular therapy, Amtagvi (lifileucel) from Iovance Biotherapeutics Inc., indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies.

Exposure to ultraviolet light is the leading cause of Melanoma, a form of skin.  Melanomas represent approximately 1% of all skin cancers yet are related to a significant number of cancer-related deaths as they metastasize. 

Amtagvi is a tumor-derived autologous T cell immunotherapy composed of a patient’s own T cells. Tumor tissue from the patient is surgically removed and their T cells are separated from the sample. The resulting therapy is then infused in the patient as a single dose. This is the first FDA-approved tumor-derived T cell immunotherapy.

Amtagvi was approved with a Boxed Warning due to prolonged severe low blood count, severe infection, cardiac disorder, respiratory or renal function failure. 

CLICK HERE for prescribing information

The company confirmed that Amtagvi will carry a list price of $515,000.


FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma

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