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 ...

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 ...

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 ...

Daiichi Sankyo and AstraZeneca’s Enhertu has been recommended for approval in the European Union as a monotherapy for the treatment of adult patients with unresectable or metast ...

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 ...

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 ...

AstraZeneca (AZN) and Daiichi Sankyo’s (DSNKY) trastuzumab deruxtecan has been recommended for approval in the European Union as a monotherapy ...

Enhertu was discovered by Daiichi Sankyo and ... The company said the test is the first and only FDA-approved for assessing HER2-low status since 2022. "The approval of our test for determining ...