On This Day in Health: April 5, 2024
On April 5, 2024, the U.S. Food and Drug Administration granted accelerated approval to Enhertu for certain advanced HER2-positive solid tumors, regardless of where the cancer began. The indication applied to adults with unresectable or metastatic tumors classified as HER2-positive by an IHC 3+ result, who had received prior systemic treatment and had no satisfactory alternative options. This was a tumor-agnostic approval: eligibility depended on a shared biological feature rather than one organ alone. The decision was the first such approval for a HER2-directed therapy and for an antibody-drug conjugate. It marked another step in cancer care organized around the characteristics of an individual tumor.
HER2 is a protein that can be present at high levels in some cancer cells. Immunohistochemistry, abbreviated IHC, is a tissue-testing method used to assess that expression. The specific IHC 3+ threshold in the approval mattered; it did not encompass every tumor with any detectable HER2 or every cancer carrying a HER2-related genetic change. Enhertu combines an antibody directed at HER2 with a cancer-killing drug payload, a design intended to bring the medicine to cells bearing the target. Previously, the treatment had approved uses in particular cancer settings. The April decision extended that logic across eligible solid tumors while retaining requirements about prior treatment and the lack of suitable alternatives.
The FDA evaluated effectiveness in 192 adults enrolled across three studies: DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02. Investigators examined confirmed tumor responses and how long those responses lasted, with assessments reviewed independently. The studies included different cancer populations, so their results were reported separately. Accelerated approval reflected those response findings and the need for additional options in advanced disease. It also meant continued approval could depend on confirmatory evidence describing clinical benefit. The distinction is essential: measurable tumor shrinkage can support a regulatory decision, but it is not identical to an established survival benefit for every cancer type. The evidence and the remaining questions were both part of the milestone.
The broader indication also reinforced the practical importance of tumor testing. A medicine defined by a biomarker can only reach an eligible patient if the relevant feature is identified and interpreted correctly. At the same time, targeted treatment still carries risks. Enhertu’s prescribing information included prominent warnings about interstitial lung disease and harm to a developing fetus, alongside other adverse effects requiring clinical supervision. April 5 therefore represents a carefully bounded expansion rather than a universal cancer treatment. Its lasting significance is the possibility of treating different cancers through a common molecular target, supported by clinical studies and accompanied by continuing obligations to establish benefit. That combination of more precise selection and ongoing evaluation captures the direction of modern oncology.
The FDA granted the tumor-agnostic accelerated approval on April 5, 2024.
Eligibility required an HER2-positive IHC 3+ advanced solid tumor and specified prior-treatment circumstances.
Enhertu links a HER2-directed antibody to a drug payload.
Effectiveness evidence came from three DESTINY studies involving 192 eligible adults.
Accelerated approval relied on response rate and duration, with confirmatory evidence still important.
Biomarker testing and careful safety monitoring remained central to the treatment’s use.
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