Supplemental New Drug Application Submitted in Japan for Trastuzumab Deruxtecan in HER2-Low Breast Cancer

A supplemental new drug application has been submitted to Japan’s Ministry of Health, Labour and Welfare (MHLW) for trastuzumab deruxtecan (Enhertu) as treatment of patients with HER2-low unresectable or recurrent breast cancer, according to a press release from Daiichi Sankyo.¹

The application is based on data from the phase 3 DESTINY-Breast04 study (NCT03734029), which assessed the drug in patients with HER2-low unresectable or metastatic breast cancer vs investigator’s choice chemotherapy. Treatment with trastuzumab deruxtecan yielded a statistically significant and clinically meaningful improvement in progression-free and overall survival, regardless of hormone receptor status.

“The positive DESTINY-Breast04 results represent the first time ever that a HER2 directed therapy has demonstrated a survival benefit in patients with HER2-low metastatic breast cancer, offering the potential to redefine how we classify and treat approximately half of all metastatic breast cancers,” Wataru Takasaki, PhD, executive officer, head of R&D Division in Japan, Daiichi Sankyo, said in the press release. “This submission to the Japan MHLW takes us one step closer to bringing trastuzumab deruxtecan to patients with metastatic breast cancer who are currently not eligible for a HER2 targeted therapy.”

Trastuzumab deruxtecan was most recently given a breakthrough therapy designation by the FDA in May 2022 in patients with HER2-low unresectable and metastatic breast cancer who were previously treated in the metastatic setting or who developed recurrent disease within 6 months of completing chemotherapy.²

References

1. Trastuzumab Deruxtecan Supplemental New Drug Application Submitted in Japan for Patients with HER2 Low Metastatic Breast Cancer. News release. Daiichi Sankyo. June 27, 2022. Accessed June 29, 2022. https://bit.ly/3uaUL5s
2. Enhertu granted breakthrough therapy designation in the US for patients with HER2-low metastatic breast cancer. News Release. AstraZeneca. April 27, 2022. Accessed April 27, 2022. https://bit.ly/3KkJjts