Trastuzumab Deruxtecan Receives EU Approval for Previously Treated Unresectable/Metastatic HER2+ Breast Cancer

The European Commission has granted approval to fam-trastuzumab deruxtecan-nxki (Enhertu) as a treatment for patients with unresectable or metastatic HER2-positive breast cancer after 1 or more prior lines of anti-HER2 therapies, according to a press release from developer AstraZeneca and Daiichi Sankyo.¹

The approval was based on findings from the phase 3 DESTINY-Breast03 trial (NCT03529110), which reported that the agent yielded a 72% reduction in risk of disease progression or death compared with trastuzumab emtansine (T-DM1; Kadcyla; HR, 0.28; 95% CI, 0.22-0.37; P <.000001).² At 12 months, the overall survival rates were 94.1% in patients in the trastuzumab deruxtecan arm and 85.9% in those in the T-DM1 arm (HR, 0.55; 95% CI, 0.36-0.86). Moreover, the overall response rate in either arm was 79.7% vs 34.2%, respectively.

“This approval is an important milestone for patients and clinicians in Europe, since previously treated patients with HER2-positive metastatic breast cancer typically experience disease progression in less than a year with historical standard of care treatment. In the DESTINY-Breast03 trial, the time to progression was extended well beyond a year for patients receiving Enhertu, illustrating the potential for this medicine to set a new benchmark in the treatment of HER2-positive metastatic breast cancer,” Javier Cortés, MD, PhD, head of the International Breast Cancer Center (IBCC), Barcelona, Spain, said in the press release.

Trastuzumab deruxtecan was previously approved by the FDA in May 2022 for the treatment of previously treated unresectable or metastatic HER2-positive breast cancer.³

References

1. Enhertu approved in the EU for patients with HER2-positive metastatic breast cancer treated with one or more prior anti-HER2-based regimens. News release. AstraZeneca and Daiichi Sankyo. July 19, 2022. Accessed July 19, 2022. https://bit.ly/3PHk4Er
2. Cortés J, Kim SB, Chung WP, et al. Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer. N Engl J Med. 2022;386(12):1143-1154. doi:10.1056/NEJMoa2115022
3. Enhertu approved in the US for patients with HER2-positive metastatic breast cancer treated with a prior anti-HER2-based regimen. News release. AstraZeneca and Daiichi Sankyo. May 5, 2022. Accessed July 19, 2022. https://bit.ly/3OZHpSs