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.
The company said the agency told it that it may consider data from an amended version of the trial of LN-145 for approval. An analyst wrote that approval could happen in the first half of 2021, based on Iovance's guidance for regulatory submission.
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