AZN: Enhertu Gets US Breakthrough Therapy Designation For HER2 Low/Ultralow Metastatic Breast Cancer

(RTTNews) - Daiichi Sankyo (DSKYF.PK) and AstraZeneca's (AZN.L, AZN) Enhertu (fam-trastuzumab deruxtecan-nxki) 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.

Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

Enhertu has received eight Breakthrough Therapy Designations, including four in 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 across Daiichi Sankyo's oncology pipeline.

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