FDA Expands Label of AZN's ENHERTU

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 Expands Label of AZN's Enhertu for New Breast Cancer Indication
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 deruxtecan) for HER2-low metastatic breast cancer in the United States.
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.
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 ).
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.
AstraZeneca, Daiichi’s drug cleared for wider use in breast cancer patients in US
Astra is due to pay Daiichi US$175 million in milestones after the US approval, the companies said. Enhertu is cleared in the US and European Union for some breast cancer patients whose cancer spread after receiving treatment, or whose disease returned after surgery.
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.
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.
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,
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AstraZeneca, Daiichi Sankyo Continue ADC Rally With Enhertu Expansion
Enhertu’s label expansion comes on the heels of the FDA’s approval of the partners' Datroway for a related type of breast ...
Enhertu approved in the US as HER2-directed therapy
AstraZeneca (AZN) and Daiichi Sankyo’s ENHERTU has been approved in the US for the treatment of adult patients with unresectable or metastatic ...
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Enhertu approved in the US as first HER2-directed…
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, ...