AstraZeneca says FDA approves Enhertu for HER2-positive early breast cancer indications

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  • AstraZeneca’s Enhertu won FDA clearance for two new HER2-positive early breast cancer uses, expanding the drug into curative-intent treatment.
  • The label now covers neoadjuvant therapy in Stage II-III disease using Enhertu followed by THP, based on the Phase III DESTINY-Breast11 trial.
  • It also covers adjuvant treatment for patients with residual invasive disease post-surgery, based on Phase III DESTINY-Breast05 data.
  • The approvals trigger USD 155 million in milestone payments from AstraZeneca to Daiichi Sankyo.


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