EU’s CHMP Recommends Fam-Trastuzumab Deruxtecan-nxki for Approval in HER2-Low Breast Cancer

Fam-trastuzumab deruxtecan-nxki has been recommended for approval by the European Union’s Committee for Medicinal Products for Human Use in patients with HER2-low advanced breast cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of fam-trastuzumab deruxtecan-nxki for patients diagnosed with unresectable or metastatic HER2-low breast cancer previously treated with chemotherapy for metastatic disease or who had recurrence on or 6 months after adjuvant chemotherapy, according to a press release from AstraZeneca.1

The opinion was supported by data from the phase 3 DESTINY-Breast04 trial (NCT03734029), which highlighted a reduction in risk of disease progression or death by 50% in those treated with trastuzumab deruxtecan compared with physician’s choice chemotherapy (HR, 0.50; 95% CI, 0.40-0.63; P < .001).2

Moreover, the median progression-free survival was 9.9 months vs 5.1 months in each respective arm. The experimental regimen also decreased the risk of death by 36% (HR, 0.64; 95% CI, 0.49-0.84; P = .001).

“[Trastuzumab deruxtecan] is the first-ever HER2-directed medicine to show a survival benefit in patients with HER2-low metastatic breast cancer, confirming the importance of targeting lower levels of HER2 expression in patients previously classified as HER2-negative,” Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca, said in a press release. The CHMP’s recommendation is encouraging and supports our ambition to evolve the way breast cancer is classified and treated to ultimately improve patient outcomes.”

The FDA approved trastuzumab deruxtecan to treat unresectable or metastatic HER2-low breast cancer in August 2022 based on data from the phase 3 DESTINY-Breast04 trial.3

References

  1. Enhertu recommended for approval in the EU by CHMP for patients with HER2-low metastatic breast cancer. News release. AstraZeneca. December 19, 2022. Accessed December 19, 2022. https://bit.ly/3uYGF7o
  2. Modi S, Jacot W, Yamashita T, et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N Engl J Med. 2022;387(1):9-20. doi:10.1056/NEJMoa2203690
  3. FDA approves first targeted therapy for HER2-low breast cancer. News Release. FDA. August 5, 2022. Accessed December 19, 2022. https://bit.ly/3BNUxWy