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OBR OncologyTrastuzumab Deruxtecan Granted Accelerated Approval for HER2-Positive Solid Tumors

First HER2-Directed Treatment Granted Tumor-Agnostic Indication

On April 5, 2024, the US Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki for the treatment of unresectable or metastatic HER2-positive solid tumors. This landmark decision marks the introduction of the first HER2-directed therapy and antibody drug conjugate available for use across a range of solid tumors, offering new hope for patients with limited treatment options.

Key Points:

  • Approval Context: Fam-trastuzumab deruxtecan-nxki (Enhertu), developed by AstraZeneca and Daiichi Sankyo, received accelerated approval for adults with unresectable or metastatic HER2-positive solid tumors who have undergone prior systemic treatments without success.
  • Trial Data: Efficacy based on 192 adult patients across three trials (DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02) with primary outcomes measuring confirmed objective response rate (ORR) and duration of response (DOR).
  • Results Overview:
    • DESTINY-PanTumor02 reported an ORR of 51.4% and a median DOR of 19.4 months.
    • DESTINY-Lung01 showed an ORR of 52.9% with a median DOR of 6.9 months.
    • DESTINY-CRC02 demonstrated an ORR of 46.9% and a DOR of 5.5 months.
  • Safety Profile: The medication comes with a Boxed Warning for interstitial lung disease (ILD) and embryo-fetal toxicity. Patients should undergo pregnancy testing and use effective contraception.
  • Adverse Effects: Common adverse effects include impacts on blood counts, liver enzymes, and gastrointestinal symptoms.
  • Usage Guidelines: Recommended dosage is 5.4 mg/kg infused intravenously every 3 weeks, continued until disease progression or unacceptable toxicity.
  • Future Considerations: Continued FDA approval may depend on further verification of clinical benefits in confirmatory trials.

Cases of human epidermal growth factor receptor 2 (HER2)-positive breast cancer represent approximately 15% to 20% of all breast cancers. (CAHO)


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