Enhertu Approved for HER2-Positive Inoperable or Metastatic Cancer in Japan

Enhertu Approved for HER2-Positive Inoperable or Metastatic Cancer in Japan
Enhertu (trastuzumab deruxtecan) has been approved in Japan to treat adults with HER2-positive inoperable or metastatic breast cancer that is resistant to chemotherapy, or those who cannot tolerate it.  Enhertu is an antibody-drug conjugate (ADC) made up of the anti-HER2 antibody trastuzumab bound to the cancer-killing compound deruxtecan (a derivative of exatecan). HER2 is a protein found on the surface of about 1 in every 5 breast cancers. The presence of HER2-positive cancer cells is linked to an aggressive form of the disease, and a poorer prognosis for patients. Developed by Daiichi Sankyo and AstraZeneca, the therapy has been designed to deliver deruxtecan directly to HER2-positive cancer cells, allowing for greater specificity and reducing off-target effects compared to conventional chemotherapy. Enhertu's approval came from Japan’s Ministry of Health, Labor, and Welfare and is based on the results of the open-label, single-arm Phase 2 DESTINY-Breast01 clinical trial (NCT03248492) in 184 women with HER2 positive metastatic breast cancer. Enhertu was given conditional approval by the U.S. Food and Drug Administration (FDA) in December to treat adults with inoperable or metastatic HER2-positive breast cancer whose disease spread despite at least two prior anti-HER2-based treatments. Full approval by the FDA will require a confirmatory study. The DESTINY-Breast01 trial evaluated the safety and efficacy of Enhertu, at a dose of 5.4 mg per kilogram of body weight, in patients with HER2-positive inoperable and/or metastatic breast cancer. All were previously treated with at least two prior HER2 therapy regimens, including the antibody-drug conjugate Kadcycla (ado-trastuzumab emtansine). The study took place across multiple centers in North Am
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