Health

ENHERTU® Plus Pertuzumab Approved in the U.S. as First New Treatment in More Than a Decade for First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer

TOKYO & BASKING RIDGE, N.J., December 15, 2025--ENHERTU Plus Pertuzumab Approved in the U.S. for First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer

articleDaiichi Sankyo Company, LimitedDecember 15, 202537/company/daiichi-sankyo-company-limited/news/enhertur-plus-pertuzumab-approved-in-the-us-as-first-new-treatment-in-more-than-a-decade-for-first-line-treatment-of-patients-with-her2-positive-metastatic-breast-cancer-1
ENHERTU® Plus Pertuzumab Approved in the U.S. as First New Treatment in More Than a Decade for First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer

About this update from Daiichi Sankyo Company, Limited

[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":480,"height":474,"url":"https://media.zenfs.com/en/business-wire.com/dacacdc477aa6073160eddf1b8e4d6d0"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/pGAQD86lCj6sUGleFMZyZQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTk0ODtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/dacacdc477aa6073160eddf1b8e4d6d0","width":480,"height":474}},"lazy":false},{"type":"list","items":[{"val":[{"type":"text","content":"Based on DESTINY-Breast09 phase 3 trial results that showed Daiichi Sankyo and AstraZeneca’s ENHERTU in combination with pertuzumab reduced the risk of disease progression by 44% versus THP with a median progression-free survival of more than three years","length":254,"tagName":"p","attribs":{}}]}],"tagName":"ul","bulletedList":true,"length":254,"olType":false},{"type":"text","content":"TOKYO & BASKING RIDGE, N.J., December 15, 2025--(BUSINESS WIRE)--ENHERTU® (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab has been approved in the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer, as determined by a U.S Food and Drug Administration (FDA)-approved test.","length":415,"tagName":"p"},{"type":"text","content":"ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).","length":229,"tagName":"p"},{"type":"text","content":"The approval was based on results from the DESTINY-Breast09 phase 3 trial, presented during a special late-breaking oral session at the 2025 American Society of Clinical Oncology (#ASCO25) Annual Meeting and subsequently published in The New England Journal of Medicine. The FDA completed the review under its Real Time Oncology Review (RTOR) program, an initiative of the FDA, following Priority Review and Breakthrough Therapy Designation of ENHERTU in combination with pertuzumab in the U.S. in this setting. The expanded approval for ENHERTU in the U.S. enables its use earlier as part of a combination regimen in the first-line setting of patients with HER2 positive metastatic bre...

More updates from Daiichi Sankyo Company, Limited

Daiichi SankyoMetastatic Breast Cancermetastatic breast cancerHER2 positiveENHERTUbreast cancerwhite blood cell countadverse reactionsbreast cancerSerious adverse reactionslymphocyte countpertuzumab