AstraZeneca announces Enhertu granted breakthrough therapy designation

Daiichi Sankyo and AstraZeneca’s Enhertu has been granted breakthrough therapy designation, or BTD, in the U.S. for the treatment of unresectable or metastatic hormone receptor positive HER2 low or HER2 ultralow breast cancer patients who have received either two lines of endocrine therapy in the metastatic setting, or one line of endocrine therapy if they had demonstrated disease progression within six months of starting first-line treatment with endocrine therapy in combination with a CDK4/6 inhibitor or within 24 months of the start of adjuvant endocrine therapy.