FDA Approves Enhertu for Earlier Use in Metastatic Breast Cancer

The FDA’s accelerated approval of Enhertu in later line HER2 positive metastatic breast cancer has now converted to regular approval.

The FDA has approved Enhertu (fam-trastuzumab deruxtecan-nxki) to treat adults with unresectable or metastatic HER2 positive breast cancer who have received a prior anti-HER2 therapy.

Developed by Daiichi Sankyo and AstraZeneca, Enhertu’s new approval was based on positive results from the pivotal DESTINY-Breast03 phase 3 trial that showed Enhertu reduced the risk of disease progression or death by 72% versus Kadcyla (trastuzumab emtansine) in patients previously treated with trastuzumab and a taxane.

The approval was granted under the FDA’s Real-Time Oncology Review (RTOR) program following the recent priority review and breakthrough therapy designation in this earlier disease setting. The previously granted accelerated approval of Enhertu in later line HER2 positive metastatic breast cancer is now converted to regular approval.

“Enhertu has demonstrated significant progression-free survival in the earlier metastatic setting, potentially establishing it as a new standard of care in previously treated patients with HER2 positive metastatic breast cancer,” Erika Hamilton, M.D., director, Breast Cancer and Gynecological Cancer Research Program at Sarah Cannon Research Institute in Nashville, said in a press release.

Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide and in the United States. More than 2 million cases of breast cancer were diagnosed in 2020 with nearly 685,000 deaths globally.In the United States, more than 290,000 new cases are expected to be diagnosed in 2022, with more than 43,000 deaths. About one in five cases of breast cancer are considered HER2 positive.

Enhertu is a HER2-directed antibody and topoisomerase inhibitor conjugate approved to the 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.