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Home » FDA Approves Datopotamab Deruxtecan / Datroway from Eli Lilly in Treatment for Unresectable or Metastatic HR-Positive, HER2-Negative Breast Cancer
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FDA Approves Datopotamab Deruxtecan / Datroway from Eli Lilly in Treatment for Unresectable or Metastatic HR-Positive, HER2-Negative Breast Cancer

EditorBy EditorFebruary 8, 2025Updated:March 4, 2025No Comments2 Mins Read
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Date: February 8, 2025

 Infographic titled "FDA Approves Datopotamab Deruxtecan-dlnk for Breast Cancer" detailing key information about the drug. It includes sections on the significance of the treatment for healthcare stakeholders, trial results from the TROPION-Breast01 study with 732 participants, a median progression-free survival (PFS) of 6.9 months for datopotamab versus 5 months for chemotherapy, a 36% confirmed objective response rate (ORR) compared to 23% with chemotherapy, a median overall survival of 18.6 months, common side effects with a 20% threshold, and the recommended dosage of 6 mg. The infographic also includes a summary noting the significance of the approval in advancing breast cancer treatment, and logos for Oncology Tube with a QR code. Property of: www.oncologytube.com

The U.S. Food and Drug Administration (FDA) has recently granted approval for datopotamab deruxtecan (DLNK), a new treatment option for adults with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. This marks a significant advancement in the fight against breast cancer, particularly for those who have progressed after prior endocrine-based therapies.

Key Points:

  • Drug Name: Datopotamab deruxtecan (DLNK)
  • Indication: Treatment for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer who have received prior systemic therapy in the metastatic setting, or have progressed within 12 months of completing adjuvant therapy.
  • Mechanism: Datopotamab deruxtecan is an antibody-drug conjugate that targets topoisomerase I inhibitor to cancer cells.

This approval provides hope and an additional therapeutic avenue for patients facing advanced stages of this type of breast cancer, potentially improving outcomes where previous treatments have failed.

For more detailed information, including clinical trial data, safety, and prescribing information, please visit the FDA’s official announcement.

Share your thoughts or experiences in the comments below. Let’s discuss how this approval might impact the breast cancer community!

This post encourages engagement by inviting comments, which could foster a community discussion around the new treatment’s implications, patient experiences, or questions about the drug. Remember to keep the conversation respectful and informative.

Related Articles:

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast

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