By Anthony O. Goriainoff
AstraZeneca PLC said Monday that the U.S. Food and Drug Administration granted its cancer treatment Enhertu a breakthrough-therapy designation for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.
HER2 refers to a breast cancer that tests positive for a protein called human epidermal growth factor receptor 2.
The U.K. pharmaceutical company said that the FDA granted the designation based on the DESTINY-Breast03 Phase 3 trial, and that this is Enhertu's second BTD in breast cancer, bringing the total number to four.
The company said Enhertu's trial showed it reduced the risk of disease progression or death by 72% in patients with HER2-positive metastatic breast cancer.
The BTD designation is designed to accelerate the development and the regulatory review of potential new medicines that are intended to treat a serious condition, the company said.
Enhertu is a HER2-directed antibody drug conjugate that is being developed jointly by AstraZeneca and Daiichi Sankyo Co.
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(END) Dow Jones Newswires