Daiichi Sankyo debuts Enhertu

Daiichi Sankyo is introducing Enhertu (fam-trastuzumab deruxtecan-nxki). Enhertu is a human epidermal growth factor receptor 2 (HER2)-directed antibody and topoisomerase inhibitor conjugate, meaning that the drug targets the changes in HER2 that help the cancer grow, divide and spread, and is linked to a topoisomerise inhibitor, which is a chemical compound that is toxic to cancer cells.

Enhertu was granted accelerated approval by the Food and Drug Administration on Dec. 20, 2019 for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. 

“Many patients with this aggressive form of metastatic breast cancer continue to face tumor progression despite being treated with two or more HER2 directed treatment regimens,” said Ken Keller, president and CEO, Daiichi Sankyo.

Keller added, “We are proud that Enhertu is now available in the United States nearly four months ahead of our original goal. Physicians now have a new specifically engineered HER2 directed antibody drug conjugate with demonstrated durable efficacy that may change the way these patients are treated.”

“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,” said Richard Pazdur, 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.

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.”