StoryRegulatory

Enhertu plus pertuzumab approved in the US as first-line treatment for HER2-positive metastatic breast cancer

Daiichi SankyoEnhertu

The FDA approved Enhertu with pertuzumab as the first treatment for HER2-positive metastatic breast cancer, the first new first-line option in more than a decade. In DESTINY-Breast09 the combination kept cancer from growing for a median 40.7 months versus 26.9 months on the long-standing standard of taxane chemotherapy, trastuzumab and pertuzumab.

  • 1,157 patients; progression-free survival HR 0.56 (44% lower risk of progression or death).
  • Complete responses 15% vs 8%.
  • Lung inflammation in 12% of patients on the combination, fatal in 0.5%.
  • Triggers a $150M milestone from AstraZeneca to Daiichi Sankyo.
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