AstraZeneca, Daiichi Sankyo ENHERTU wins FDA nod in HER2-positive early breast cancer

AstraZeneca PLC

AstraZeneca PLC

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  • AstraZeneca’s Enhertu won FDA clearance for neoadjuvant use in adults with HER2-positive Stage II-III early breast cancer, expanding the drug into the curative-intent setting.
  • The label also now covers adjuvant use for patients with residual invasive disease following trastuzumab-based therapy and taxane chemotherapy.
  • A milestone payment of USD 155 million is due from AstraZeneca to partner Daiichi Sankyo following the two US approvals.


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