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 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 expands Enhertu approval to include HER2-ultralow breast cancer patients
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 breast cancer patients with very low levels of HER2 protein.
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/Daiichi Sankyo’s Enhertu granted FDA approval in breast cancer
AstraZeneca (AZ) and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved by the US Food and Drug Administration (FDA) to treat a new subset of breast cancer patients.
AstraZeneca-Daiichi Sankyo Enhertu gets USFDA approval for HER2-ultralow metastatic breast cancer
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
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 And Daiichi Sankyo's ENHERTU For HER2-Low/Ultralow Breast Cancer
The U.S. Food and Drug Administration has approved AstraZeneca Plc. (AZN.L, AZN) and Daiichi Sankyo's (DSKYF.PK) ENHERTU
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,
Pharm Exec3d
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, ...
BioSpace3d
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 ...
FiercePharma9h
Fierce Pharma Asia—Takeda's next CEO; Enhertu's novel FDA nod; East Asian American C-suite execs
Takeda is promoting U.S. chief Julie Kim to be its next CEO. AstraZeneca and Daiichi's Enhertu has won an FDA nod to expand into HER2-ultralow breast cancer. | Takeda is promoting U.S. chief Julie Kim ...