The US Food and Drug Administration (FDA) approval of lifileucel, for advanced melanoma, represents the first cellular therapy to reach the clinic for solid cancers. Here, we summarise this landmark approval, consider the associated regulatory pathway, and evaluate the challenges that remain to ensure effective implementation of this advanced 'living' therapy.
Keywords: FDA approval; cell therapy; immunotherapy; lifileucel; melanoma; tumour infiltrating lymphocyte therapy.
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