AstraZeneca Enhertu wins FDA approval for HER2-positive early breast cancer use before surgery

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  • AstraZeneca, partner Daiichi Sankyo won FDA clearance for Enhertu in HER2-positive early breast cancer for neoadjuvant use in Stage II-III disease and adjuvant use in patients with residual invasive disease post-surgery.
  • Approvals expand Enhertu into curative-intent treatment, supported by Phase III DESTINY-Breast11 and DESTINY-Breast05 data.
  • AstraZeneca owes Daiichi Sankyo USD 155 million in milestone payments tied to the two new indications.


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