Enhertu, with new OK, set to supplant chemo in HER2-low breast cancer
The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety of tumors.
FDA expands Enhertu approval to include HER2-ultralow breast cancer patients
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 H
FDA Approves AstraZeneca, Daiichi Sankyo’s Enhertu for Unresectable or Metastatic Hormone Receptor-Positive, HER2-Low Breast Cancer
Approval of Enhertu marks the first HER2-directed therapy indicated for adults with unresectable or metastatic HR-positive, HER2-low, or HER2-ultralow metastatic breast cancer.
Enhertu Approved for HR+, HER2-Low/Ultralow Metastatic Breast Cancer
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: NCT04494425 ).
AZ, Daiichi's Enhertu nabs 7th FDA nod, including in 'HER2-ultralow' use, in breast cancer first
Just 11 days after AstraZeneca and Daiichi Sankyo gained FDA approval | The FDA has cleared AstraZeneca and Daiichi Sankyo's 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 endocrine therapies.
FDA Approves Trastuzumab Deruxtecan for HER2-Low/Ultralow Breast Cancer
The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.
Enhertu gets first okay for HER2-ultralow breast cancer
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-ultralow metastatic breast cancer.
FDA Approves AstraZeneca, Daiichi Sankyo's Enhertu For Certain Type Of Breast Cancer Patients
FDA approves Enhertu for metastatic breast cancer with HER2-low or HER2-ultralow expression after showing significant efficacy in the DESTINY-Breast06 trial.
FDA Approves T-DXd in HR+, HER2-Low/Ultralow Breast Cancer
The FDA approved trastuzumab deruxtecan for adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast cancer, based on phase 3 DESTINY-Breast06 trial results.
FDA Approves Enhertu for HER2-Low and -Ultralow Breast Cancer
The antibody drug conjugate was approved for patients with unresectable or metastatic HER2-low or -ultralow breast cancer with disease progression after endocrine therapy.
AstraZeneca Receives FDA Approval for Enhertu Breast Cancer Treatment
AstraZeneca received Food and Drug Administration approval for enhertu, its breast cancer treatment developed in partnership with Japanese company Daiichi Sankyo. The Anglo-Swedish pharmaceutical company said Monday that the treatment's approval was based on results from a Phase III trial,
In HER2+ colorectal cancer, anti-HER2 therapy may be less toxic alternative
Patients whose metastatic colorectal cancer has progressed following chemotherapy and who lack mutations in the RAS and BRAF ...
Targeted Oncology18h
A New AI Tool Assists Pathologists in Assessing HER2 0 vs 1+ in Breast Cancer
Pathologists supported by a new artificial intelligence tool outperformed Standard of Care/Gold standard in determining ...