Enhertu is designed to target the HER2 protein, which helps cancer grow, divide and spread. HER2-positive breast cancer is an aggressive form of breast cancer.
In a clinical trial, 60.3 percent of patients saw tumor shrinkage.
The drug comes with a risk for interstitial lung disease as well as embryo-fetal toxicity.
The FDA advised that healthcare professionals monitor Enhertu patients for symptoms including cough, difficult or labored breathing, fever and other new or worsening respiratory symptoms. If such symptoms arise, Enhertu should be withheld, the dose reduced or the drug permanently discontinued.
Women who are pregnant should not take Enhertu because it may harm a developing fetus or newborn baby or cause delivery complications.
Enhertu was granted breakthrough therapy designation and fast-track designation.
Read the full news release here.
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