FDA Approves Enhertu as Neoadjuvant, Adjuvant Treatment for Breast Cancer

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By Lori Solomon HealthDay Reporter

Medically reviewed by Drugs.com

via HealthDay

FRIDAY, May 22, 2026 -- The U.S. Food and Drug Administration has approved Enhertu (fam-trastuzumab deruxtecan-nxki) for both the neoadjuvant and adjuvant treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer.

Enhertu was approved in the neoadjuvant setting to be followed by treatment with a taxane, trastuzumab, and pertuzumab (THP) in adult patients with HER2-positive stage II or III breast cancer. For adjuvant use, Enhertu was approved for the treatment of adult patients with HER2-positive breast cancer with residual invasive disease following trastuzumab (with or without pertuzumab) and taxane-based treatment.

The approval was based on results from two phase 3 trials. In DESTINY-Breast11, neoadjuvant treatment with Enhertu followed by THP showed a pathologic complete response rate of 67.3 percent versus 56.3 percent for dose-dense doxorubicin and cyclophosphamide followed by THP. In DESTINY-Breast05, adjuvant treatment with Enhertu showed a reduction in the risk for invasive disease recurrence or death (invasive disease-free survival) by 53 percent versus trastuzumab emtansine (T-DM1) in patients with HER2-positive breast cancer with residual invasive disease following neoadjuvant therapy (hazard ratio, 0.47). At three years, 92.4 percent of patients treated with Enhertu were alive and free of invasive disease compared with 83.7 percent treated with T-DM1.

"HER2-positive early disease is considered highly curable; however, up to one in four patients still experience disease recurrence, underscoring the need for new options in this setting," Dave Fredrickson, executive vice president for the oncology hematology business unit at AstraZeneca, said in a statement. "These approvals mark an important step forward, expanding the possibility of cure to more patients for the first time in many years and positioning Enhertu as a foundational treatment in early breast cancer."

Approval of Enhertu was granted to AstraZeneca.

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Source: HealthDay

Posted : 2026-05-23 02:29

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