06:50 AM EDT, 08/19/2024 (MT Newswires) -- AstraZeneca ( AZN ) and Daiichi Sankyo said Monday that Enhertu has been granted US Food and Drug Administration Breakthrough Therapy Designation for the treatment of some breast cancer indications.

The companies said the designation applies to the treatment of inoperable or metastatic hormone receptor-positive HER2 low or ultra-low breast cancer in patients who have already received either two lines of endocrine therapy, or who have tried a single course of endocrine therapy and shown other signs of resistance to treatments.

Enhertu, also known as fam-trastuzumab deruxtecan-nxki, was discovered by Daiichi Sankyo and is being developed and commercialized in partnership with AstraZeneca ( AZN ).

Breakthrough status accelerates regulatory review of potential new medicines addressing serious conditions. The designation is based on data from a phase 3 clinical trial presented this year.

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