FDA accelerated approval for Enhertu in HER2-positive solid tumors, dated April 5, 2024
The FDA's own posting records accelerated approval for fam-trastuzumab deruxtecan-nxki for adults with unresectable or metastatic HER2-positive solid tumors.
The FDA's record states that on April 5, 2024, the Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory1 treatment alternative, based on the text as posted.
The document excerpt provided ends at that point, so it is not possible to confirm from this source what additional detail, trial data, dosing information, or post-marketing requirements the full FDA record may contain. Readthrough will update this entry if the complete record becomes available.
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