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

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 ...

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 deal with RemeGen gives Seagen a closer rival to AZ and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) and Roche's Kadcyla (trastuzumab emtansine) – both HER2-targeting ADCs – but may ...

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 ...

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, ...