Daiichi Sankyo obtains FDA approval for Enhertu

Daiichi Sankyo has received the Food and Drug Administration’s approval for Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.

"There have been many advances in the development of drugs for HER2-positive breast cancer since the introduction of Herceptin (trastuzumab) in 1998. The approval of Enhertu represents the newest treatment option for patients who have progressed on available HER2-directed therapies," Richard Pazdur, the director of the FDA's oncology center of excellence and acting director of the office of oncologic diseases in the FDA's center for drug evaluation and research, said.

Pazdur added,"Drug development in the area of targeted therapies builds on our scientific understanding of malignant diseases not only in breast cancer, but in multiple other diseases."