The U.S. Food and Drug Administration has granted approval for ENHERTU, a drug jointly developed by AstraZeneca Plc. and Daiichi Sankyo, for the treatment of adult patients with specific types of advanced breast cancer. This approval encompasses cases of unresectable or metastatic hormone receptor-positive, HER2-low, and HER2-ultralow breast cancer. The cancer must have progressed following one or more endocrine therapies in a metastatic context and be identified via an FDA-approved test.
ENHERTU, a meticulously engineered HER2-directed DXd antibody-drug conjugate, was discovered by Daiichi Sankyo. It is now being collaboratively developed and marketed by both AstraZeneca and Daiichi Sankyo.
This drug already has approval in over 75 countries, including the United States, for patients experiencing HER2-low metastatic breast cancer who have previously undergone systemic therapy or whose disease reappeared within six months of completing adjuvant chemotherapy, as demonstrated in the DESTINY-Breast04 trial. Subsequent regulatory applications are currently under examination in the European Union, Japan, and several other nations, informed by findings from the DESTINY-Breast06 trial.
On Monday, AstraZeneca shares closed the regular trading session at $70.08, marking an increase of $1.02 or 1.48%.
