Enhertu gains expanded label in new classification of HER2-low patients

Less than two weeks after AstraZeneca and Daiichi Sankyo said FDA granted priority review to Enhertu in a HER2-low breast cancer population, FDA has approved the antibody-drug conjugate, allowing the drug to reach a new classification of patients.

The rapid regulatory turnaround will make Enhertu fam-trastuzumab deruxtecan-nxki available to about 60% of breast cancer patients who weren’t previously eligible for HER2-targeted therapies, and will completely redefine how breast cancers are classified...