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

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 ...

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 U.S. regulator has cleared Enhertu as the first HER2-directed treatment for patients with HER2-low or HER2-ultralow metastatic breast cancer following disease progression after one or more ...

By analyzing ERBB2 mRNA expression data, researchers identified a group of HER2-negative patients with poor outcomes and potential markers of treatment resistance.

ENHERTU is the only FDA-approved drug used as the treatment approach for patients with HER2 NSCLC. ENHERTU is a conjugate of a HER2-targeted antibody and topoisomerase inhibitor, approved for ...

Shares of solid tumor concern Zymeworks Inc. have barely budged since the company obtained its first approval. Click here to ...

Enhertu is approved for HR-positive, HER2-low or -ultralow metastatic breast cancer after endocrine therapy progression, based on DESTINY-Breast06 trial results. Enhertu showed a 36% reduction in ...

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: ...

Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In 2022, the drug became the first therapy approved for HER2-low breast ...

Some of the key HER2+ NSCLC therapies in the pipeline include Pyrotinib, Zongertinib, BAY2927088, FWD1509, ORIC-114, IAM1363, Firmonertinib, XMT-2056, NVL-330, and others. In September 2024, ...