AstraZeneca, Daiichi Sankyo Win FDA Breakthrough Therapy Designation for Breast Cancer Drug

MT Newswires Live

Jul 18, 2025

AstraZeneca (AZN) and Daiichi Sankyo won breakthrough therapy designation from the US Food and Drug Administration for Enhertu, in combination with pertuzumab, as a treatment for adults with unresectable or metastatic HER2 positive breast cancer.

The designation was based on a Phase 3 trial of 1,157 patients across five continents that evaluated Enhertu, alone or with pertuzumab, against the standard first-line regimen of taxane, trastuzumab, and pertuzumab, the companies said Thursday in a statement.

Enhertu was discovered by Daiichi Sankyo and is being developed and commercialized jointly by the Tokyo-based company and AstraZeneca.

Shares of AstraZeneca fell 1.2% in recent Thursday trading.

Price: 69.24, Change: -0.84, Percent Change: -1.20

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