FDA Announces Approval of TIL Therapy or AMTAGVI™

On February 16 the FDA announced the approval of TIL therapy or AMTAGVI™ the first cellular therapy indicated for the treatment of adult patients with cutaneous (skin) 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.  

Since 2011, 16 drugs have been FDA approved that can be used singly or in combination to treat 31 melanoma indications in adult and pediatric patients, including two drugs approved specifically for metastatic uveal (eye) melanoma.  While work remains to improve long term survival rates in subpopulations of melanoma patients, these drugs have increased the survival rate for metastatic cutaneous (skin) melanoma patients by nearly 50%.  

For more information about the FDA approval of TIL therapy or AMTAGVI™, view the announcement press release.