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 ...

Roche has secured a new FDA approval for its first companion diagnostic test aimed at identifying breast cancer patients with ...

Enhertu may cause mild side effects other than the ones listed. See the Enhertu prescribing information for details. For more information about some of these side effects and how to manage them ...

Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In ...

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 ...

The U.S. Food and Drug Administration has approved AstraZeneca Plc. (AZN.L, AZN) and Daiichi Sankyo's (DSKYF.PK) ENHERTU ...

Enhertu reduced the risk of disease progression or death by 36%, with a median PFS of 13.2 months versus 8.1 months for chemotherapy. The trial showed an ORR of 62.6% for Enhertu compared to 34.4% ...

The prescribing information for Enhertu also includes a Boxed Warning regarding the risk of interstitial lung disease and embryo-fetal toxicity. Enhertu is supplied in a single-dose vial ...

Trastuzumab deruxtecan (Enhertu; AstraZeneca, Daiichi Sankyo) is a HER2-directed antibody-drug conjugate. The agent is approved in the United States for several indications, including treatment of ...