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Datopotamab Deruxtecan: First Approval

Hannah A Blair1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

Drugs
|May 5, 2025
PubMed

Insights

Datopotamab deruxtecan, a TROP2-directed antibody-drug conjugate, has gained approval in Japan, the USA, and the EU for specific breast cancer types. This marks a significant milestone in treating hormone receptor-positive, HER2-negative advanced breast cancer.

Area of Science:

  • Oncology
  • Pharmacology
  • Drug Development

Background:

  • Datopotamab deruxtecan (DATROWAY®) is an antibody-drug conjugate targeting trophoblast cell surface antigen 2 (TROP2).
  • It is developed by Daiichi Sankyo and AstraZeneca for treating solid tumors.
  • This conjugate represents a novel therapeutic approach in oncology.

Purpose of the Study:

  • To summarize the development milestones of datopotamab deruxtecan.
  • To highlight its recent approvals for specific breast cancer indications.
  • To provide an overview of its regulatory journey.

Main Methods:

  • Review of regulatory filings and clinical development data.
  • Analysis of approval dates and geographical regions.
  • Summary of patient populations and prior treatment criteria.

Main Results:

  • Datopotamab deruxtecan received approval in Japan (December 27, 2024) for HR+, HER2- unresectable or recurrent breast cancer post-chemotherapy.
  • US approval (January 17, 2025) was granted for unresectable or metastatic HR+, HER2- breast cancer with prior endocrine-based therapy and chemotherapy.
  • EU approval was obtained for unresectable or metastatic HR+, HER2- breast cancer following endocrine therapy and at least one line of chemotherapy.

Conclusions:

  • Datopotamab deruxtecan has achieved significant regulatory milestones with its initial approvals.
  • These approvals target a specific, unmet need in HR+, HER2- advanced breast cancer.
  • Further regulatory reviews are ongoing in Canada and China.

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