The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety of tumors.

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

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.

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.

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 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 Enhertu for metastatic breast cancer with HER2-low or HER2-ultralow expression after showing significant efficacy in the DESTINY-Breast06 trial.

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.