Dr. Debu Tripathy breaks down the FDA approval of Enhertu in unresectable or metastatic HR-positive, HER2-low or -ultralow ...

Enhertu is a HER2-directed antibody and topoisomerase inhibitor conjugate. Approval of the new indication was based on data from the phase 3 DESTINY-Breast06 trial (ClinicalTrials.gov Identifier: ...

Dr. Debu Tripathy discusses the FDA approval of Enhertu in unresectable or metastatic hormone receptor HR+, HER2-low or ...

Enhertu is a HER2-directed antibody and topoisomerase ... Study participants with HR-positive, HER2-low or HER2-ultralow metastatic breast cancer who disease had progressed on endocrine therapy ...

Patients with tumours that are HER2-low or HER2-ultralow now have more options to consider with their healthcare team.” In the trial, Enhertu showed a 36% reduction in the risk of disease progression ...

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received approval from the US Food and Drug Administration (FDA) for an expanded indication of ...

AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application (sBLA) seeking approval for expanded use of Enhertu (trastuzumab ...

AZ and Daiichi Sankyo already claimed FDA approval for the HER2-low indication in the US last summer, adding to Enhertu's lengthening list of indications, which also includes second- and third ...

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The U.S. regulator has cleared Enhertu as the first HER2-directed treatment for patients with HER2-low or HER2-ultralow metastatic breast cancer following disease progression after one or more ...

Approval of Enhertu marks the first HER2-directed therapy indicated for adults with unresectable or metastatic HR-positive, HER2-low, or HER2-ultralow metastatic breast cancer. The FDA has approved ...