Daiichi Sankyo Enhertu wins FDA approval in HER2-positive early breast cancer indications

  • Daiichi Sankyo secured FDA clearance for Enhertu use in two curative-intent settings for HER2-positive early breast cancer, expanding franchise beyond metastatic disease.
  • Decision drew on two phase 3 studies where results were already presented at 2025 ESMO Congress, with peer-reviewed publications in Annals of Oncology and New England Journal of Medicine.
  • Neoadjuvant study showed regimen built around Enhertu increased likelihood of eliminating detectable invasive cancer at surgery versus a standard chemotherapy-based approach.
  • Adjuvant study showed Enhertu lowered risk of cancer returning or death versus Roche’s Kadcyla in patients with residual invasive disease following pre-surgery HER2-targeted therapy.
  • Approvals trigger USD 155 million in milestone payments from AstraZeneca to Daiichi Sankyo, split USD 30 million for neoadjuvant use and USD 125 million for adjuvant use.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Daiichi Sankyo Co. Ltd. published the original content used to generate this news brief via Business Wire (Ref. ID: 202605151831BIZWIRE_USPR_____20260513_BW022601) on May 15, 2026, and is solely responsible for the information contained therein.

This page is machine-translated. Sahm tries to improve but does not guarantee the accuracy and reliability of the translation, and will not be liable for any loss or damage caused by any inaccuracy or omission of the translation. *Disclaimer: The above content only represents the author's personal position and opinion and does not represent any position of Sahm Capital Financial Company and Sahm cannot confirm the authenticity, accuracy, and originality of the above content. Investors should consider the risks of investment products in light of their circumstances before making any investment decisions. When necessary, please consult a professional investment advisor. Sahm does not provide any investment advice, nor does it make any commitments and guarantees.