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 ...

Dr. Debu Tripathy discussed the importance of understanding the distinctions between HER2-low and HER2-ultralow breast cancer ...

The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...

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 ...

The FDA approved Datroway to treat metastatic or unresectable HR+/HER2- breast cancer in people who have tried standard chemo ...

The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which identifies patients with HR–positive, HER2-ultralow metastatic breast ...

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 ...

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 ...