ENHERTU Receives Japanese Approval for HER2-Low Breast Cancer

On June 27, 2022, Daiichi Sankyo Co., Ltd. announced that its HER2-antibody-drug conjugate ENHERTU has received manufacturing and marketing approval in Japan for an additional indication: patients with HER2-low breast cancer.

Breast cancer is the most common cancer among women in Japan, with approximately 90,000 cases reported in 2020. HER2 is a protein expressed on the surface of cancer cells and is also present in gastric, colorectal, and lung cancers. Approximately half of breast cancer patients have HER2-low expression, and there were previously no antibody-drug conjugates targeting this group.

This approval is based on the results of the DESTINY-Breast04 Phase III clinical trial. The trial compared ENHERTU (N=557) with physician's choice of chemotherapy (N=373) in patients with previously treated HER2-low breast cancer. The results showed that both hormone receptor-positive patients and the overall patient population achieved significant improvements in progression-free survival (PFS) and overall survival (OS).

Daiichi Sankyo stated in its press release that the approval provides a new treatment option for HER2-low breast cancer patients and will contribute to the treatment of more breast cancer patients in Japan.

The results of the DESTINY-Breast04 trial were also presented at the American Society of Clinical Oncology (ASCO 2022) and published in the medical journal "The New England Journal of Medicine."

Source: https://www.daiichisankyo.co.jp/files/news/pressrelease/pdf/202206/20220627_J2.pdf

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