European Medicines Agency Recommends T-DXd for Approval in European Union in Advanced HER2+ Breast Cancer

The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended for approval trastuzumab deruxtecan for patients with unresectable or metastatic HER2-positive breast cancer.

Trastuzumab deruxtecan (T-DXd; Enhertu) has been recommended for approval by the European Medicines Agency for patients with unresectable or metastatic HER2-positive breast cancer who have received 1 or more prior anti-HER2-based regimens, according to a press release from AstraZeneca.1

The recommendation for approval, which was made by the Committee for Medicinal Products for Human Use, is based on results from the phase 3 DESTINY-Breast03 trial (NCT03529110) assessing T-DXd vs trastuzumab emtansine (T-DM1; Kadcyla) for patients with HER2-positive metastatic breast cancer.2 Topline results included a reduction in the risk of death or disease progression by 72% in the T-DXd arm vs the T-DM1 arm (HR, 0.28; 95% CI, 0.22-0.37; P <.0001).

“This recommendation reflects the transformative progression-free survival benefit seen in the DESTINY-Breast03 trial compared [with] T-DM1, supporting [T-DXd] as a potential new standard of care and setting a new benchmark in the treatment of HER2-positive metastatic breast cancer. If approved by the European Commission, patients in Europe may be able to benefit from this important medicine earlier in the treatment of their disease, improving their chance for better outcomes,” Susan Galbraith, executive vice president of Oncology Research and Development at AstraZeneca, said in the press release.

The FDA approved T-DXd in May 2022 for patients with unresectable or metastatic HER2-positive breast cancer.3 Moving forward, the European Commission will evaluate the treatment for the indicated patient population and decide on its approval.

References

  1. Enhertu recommended for approval in the EU by CHMP for patients with HER2-positive metastatic breast cancer treated with a prior anti-HER2-based regimen. News Release. AstraZeneca. June 27, 2022. Accessed June 28, 2022. https://bit.ly/3ORjOCF
  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. May 5, 2022. Accessed June 28, 2022. https://bit.ly/3OZHpSs