MedCity News February 19, 2024
Frank Vinluan

Iovance Biotherapeutics’s Amtagvi is now the first FDA-approved treatment based on type of cell called a tumor-infiltrating lymphocyte. The regulatory nod in advanced melanoma also makes Amtagvi the first cell therapy approved for treating a solid tumor.

Engineering a patient’s immune cells into cancer treatments works for treating blood cancers, but has fallen short in solid tumors—until now. An Iovance Biotherapeutics treatment employing a different type of cell has won accelerated FDA approval for advanced melanoma, marking the first product approval of any cell therapy for a solid tumor.

The regulatory decision announced Friday covers melanoma in adults whose cancer cannot be surgically removed or has spread following treatment with an immunotherapy or a targeted cancer therapy. The cell therapy...

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