Enhertu Receives U.S. Breakthrough Therapy Designation for HER2 Low/Ultralow Metastatic Breast Cancer

LONDON (dpa-AFX) – Daiichi Sankyo (DSKYF.PK) and AstraZeneca’s (AZN.L, AZN) Enhertu (fam-trastuzumab deruxtecan-nxki) have been granted Breakthrough Therapy Designation, or BTD, in the U.S. for the treatment of unresectable or metastatic hormone receptor-positive patients with low HER2 or ultra-low HER2 breast cancer who have received either two lines of endocrine therapy in the metastatic setting or one line of endocrine therapy if they experienced disease progression within six months of starting first-line endocrine therapy in combination with a CDK4/6 inhibitor or within 24 months of starting adjuvant endocrine therapy.

Enhertu is a specially designed HER2-targeted DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

Enhertu has received eight Breakthrough Therapy Designations, including four for metastatic breast cancer. In addition to the new Breakthrough Therapy Designation, the three previous BTDs for breast cancer were for later-line HER2 low metastatic breast cancer, second-line HER2 positive metastatic breast cancer, and later-line HER2 positive metastatic breast cancer.

Enhertu also received four additional BTDs, including for HER2-positive metastatic solid tumors, HER2-positive metastatic colorectal cancer, HER2 (ERBB2)-mutant metastatic non-small cell lung cancer (NSCLC), and HER2-positive metastatic gastric cancer. The new BTD for Enhertu also represents the eleventh BTD in Daiichi Sankyo’s oncology pipeline.

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