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

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

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 ...

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: ...

The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, human epidermal ...

The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan ... with HR and HER status determined by an FDA-approved test. Additionally, patients had to have had disease ...

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 ...

How low could Enhertu go? The FDA’s answer came on Tuesday. In addition to becoming the first treatment for those whose tumors show a lower level of the HER2 protein biomarker, the nod moves ...

Enhertu reduced the risk of disease progression ... that uncovers hidden opportunities in the post-earnings chaos. The FDA granted the approval after securing Priority Review and Breakthrough ...

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 ...

Enhertu received an FDA nod in HER2-ultralow breast cancer in late January, its seventh agency approval, for treatment following the disease’s progression after endocrine therapy. Roche’s ...