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

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 ...

Get Instant Summarized Text (Gist) The FDA has approved Enhertu for treating adults with unresectable or metastatic HR-positive, HER2-low, or HER2-ultralow breast cancer. This approval follows the ...

AstraZeneca and Daiichi Sankyo have claimed their seventh FDA approval for Enhertu, getting the go-ahead for the blockbuster drug as a second-line treatment for patients with HER2-low and HER2 ...

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 ...

In the HER2-low population, treatment with trastuzumab deruxtecan reduced the risk of disease progression or death by 38% compared with chemotherapy. The Food and Drug Administration (FDA) has ...

1. Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for Enhertu. Roche. News release. January 31 ...

Just days after the FDA approved AstraZeneca and Daiichi Sankyo's Enhertu for a potentially lucrative new use, the regulatory has now cleared a diagnostic test that could help unlock the drug's ...

ENHERTU is a specifically engineered HER2-directed antibody drug conjugate (ADC ... The PATHWAY HER2 (4B5) test has now received approval to identify a new patient population designated as ...