AstraZeneca, Daiichi Sankyo's ENHERTU Wins FDA's Breakthrough Therapy Designation In US

(RTTNews) - AstraZeneca PLC (AZN), along with pharmaceutical company Daiichi Sankyo, Monday announced that fam-trastuzumab deruxtecan-nxki, sold under the brand name ENHERTU, has been granted the Food and Drug Administration's Breakthrough Therapy Designation in the U.S. for adult patients.

The drug is used to treat HER2-positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant treatment and high risk of disease recurrence.

The designation is supported by data from the DESTINY-Breast05 Phase III trial, which demonstrated that ENHERTU may help halt invasive disease recurrence over the current standard of care.

In the pre-market hours, AZN is trading at $91.38, up 0.07 percent on the Nasdaq.