{"id":942830,"date":"2026-03-09T07:03:16","date_gmt":"2026-03-09T11:03:16","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/enhertu-fam-trastuzumab-deruxtecan-nxki-granted-priority-review-in-the-us-as-post-neoadjuvant-treatment-for-patients-with-her2-positive-early-breast-cancer\/"},"modified":"2026-03-09T07:03:16","modified_gmt":"2026-03-09T11:03:16","slug":"enhertu-fam-trastuzumab-deruxtecan-nxki-granted-priority-review-in-the-us-as-post-neoadjuvant-treatment-for-patients-with-her2-positive-early-breast-cancer","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/enhertu-fam-trastuzumab-deruxtecan-nxki-granted-priority-review-in-the-us-as-post-neoadjuvant-treatment-for-patients-with-her2-positive-early-breast-cancer\/","title":{"rendered":"ENHERTU\u00ae (fam-trastuzumab deruxtecan-nxki) granted Priority Review in the US as post-neoadjuvant treatment for patients with HER2-positive early breast cancer"},"content":{"rendered":"

<\/p>\n

ENHERTU\u00ae (fam-trastuzumab deruxtecan-nxki) granted Priority Review in the US as post-neoadjuvant treatment for patients with HER2-positive early breast cancer<\/b><\/p>\n

Based on DESTINY-Breast05 Phase III trial results which showed ENHERTU reduced the risk of invasive disease recurrence or death by 53% compared with <\/i><\/b>T-DM1<\/i><\/b><\/p>\n

If approved, AstraZeneca and Daiichi Sankyo\u2019s ENHERTU has the potential to become a new standard of care in this early breast cancer setting<\/i><\/b><\/p>\n

WILMINGTON, Del.–(BUSINESS WIRE<\/a>)–
\nAstraZeneca and Daiichi Sankyo\u2019s supplemental Biologics License Application (sBLA) for ENHERTU\u00ae<\/sup> (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the US for the treatment of adult patients with HER2-positive breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment.<\/p>\n

\nThe Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for its regulatory decision, is anticipated during the third quarter of 2026.<\/p>\n

\nENHERTU was recently granted<\/a> Breakthrough Therapy Designation (BTD) by the FDA in this setting. BTD accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need.<\/p>\n

\nThe sBLA also is being reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners.<\/p>\n

\nAround one in five breast cancers are considered HER2-positive, a subtype that is often associated with aggressive disease and poor prognosis.1-3<\/sup> Currently, approximately half of patients with HER2-positive early breast cancer have residual disease following neoadjuvant treatment (before surgery), putting them at an increased risk of disease recurrence.4-9 <\/sup>Despite receiving additional treatment in the post-neoadjuvant setting with current standards of care, some patients still experience tumor progression to metastatic disease, where the five-year survival rate drops from nearly 90% to approximately 30%.10,11<\/sup><\/p>\n

\nSusan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: \u201cWhile there has been significant progress in treating HER2-positive early breast cancer, managing patients at a higher risk of recurrence remains challenging. With this Priority Review, we move closer to bringing ENHERTU to the post-neoadjuvant setting, offering more patients the opportunity for sustained long-term outcomes and a potential path to cure.\u201d<\/p>\n

\nKen Takeshita, Global Head, R&D, Daiichi Sankyo, said: \u201cFor patients with residual invasive disease after neoadjuvant therapy, identifying additional treatments following surgery is critical to help further reduce the risk of recurrence and help prevent progression to metastatic disease. This Priority Review reinforces the potential of ENHERTU to become a new standard of care for HER2-positive early breast cancer based on the results of DESTINY-Breast05.\u201d<\/p>\n

\nThe sBLA is based on data from the DESTINY-Breast05<\/a> Phase III trial presented at the European Society for Medical Oncology (ESMO) 2025 Congress and subsequently published in The New England Journal of Medicine<\/i><\/a>.1<\/sup><\/p>\n

\nIn the trial, ENHERTU significantly reduced the risk of invasive disease recurrence or death (invasive disease-free survival [IDFS]) by 53% compared with trastuzumab emtansine (T-DM1; based on a hazard ratio [HR] of 0.47; 95% confidence interval [CI] 0.34-0.66; p<0.0001) as a post-neoadjuvant treatment for patients with HER2-positive breast cancer. ENHERTUdemonstrated a three-year IDFS rate of 92.4% compared with 83.7% with T-DM1. IDFS findings were consistent across all prespecified subgroups.<\/p>\n

\nENHERTU also significantly reduced the risk of disease recurrence or death (disease-free survival [DFS]), a key secondary endpoint, by 53% versus T-DM1 (HR 0.47; 95% CI 0.34-0.66; p<0.0001). Further, ENHERTU lowered the risk of distant disease recurrence (distant recurrence-free interval) by 51% and the risk of brain metastases (brain metastasis-free interval) by 36% compared with T-DM1 (HR 0.64; 95% CI 0.35-1.17).<\/p>\n

\nThe safety profile of ENHERTU observed in DESTINY-Breast05 was consistent with its known profile with no new safety concerns identified.<\/p>\n

\nRegulatory submissions for ENHERTUbased upon DESTINY-Breast05 are also under review in the EU and Japan. In addition, an sBLA for ENHERTUfollowed by paclitaxel, trastuzumab and pertuzumab (THP) currently is under review<\/a> in the US for the neoadjuvant treatment of patients with HER2-positive early breast cancer based on results from the DESTINY-Breast11 trial<\/a>.<\/p>\n

\nENHERTU is already approved in more than 90 countries as a treatment for patients with HER2-positive metastatic breast cancer.<\/p>\n

\nENHERTU is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.<\/p>\n

INDICATION AND IMPORTANT SAFETY INFORMATION FOR ENHERTU\u00ae<\/sup> (fam-trastuzumab deruxtecan-nxki)<\/b><\/p>\n

Indications
\n
<\/b>ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated:<\/p>\n