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Key Terms<\/p>\n
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\n chmp
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\n regulatory
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The CHMP is the European Medicines Agency\u2019s expert panel that evaluates whether a medicine for people should be recommended for approval across the EU. Think of it as a technical review board whose positive or negative opinion strongly affects a drug maker\u2019s ability to sell a product in the European market, shaping potential revenues, regulatory risk and investment timelines for companies developing or marketing therapies.<\/p>\n
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\n antibody drug conjugate
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\n medical
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An antibody drug conjugate is a targeted medical treatment that combines a special antibody with a powerful drug, allowing precise delivery of the medicine directly to cancer cells or other harmful cells in the body. For investors, it represents a sophisticated approach to therapy that could improve treatment effectiveness and reduce side effects, potentially leading to significant growth opportunities in the biotech and pharmaceutical sectors.<\/p>\n
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\n hazard ratio
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\n technical
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A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.<\/p>\n
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\n progression-free survival
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\n medical
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Progression-free survival is the length of time during and after a treatment that a patient’s disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential\u2014think of it as a stopwatch showing how long a therapy can keep the illness at bay.<\/p>\n
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\n objective response rate
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\n medical
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The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug\u2019s ability to produce a clear treatment effect\u2014like counting how many plants visibly respond after applying a new fertilizer\u2014and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.<\/p>\n
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\n interstitial lung disease
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\n medical
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A group of lung conditions that cause inflammation and scarring of the thin tissue between the air sacs, which makes it harder for oxygen to pass into the blood; imagine the lungs\u2019 fine filters becoming stiff and less effective. Investors care because reports of interstitial lung disease can affect a drug\u2019s safety profile, trigger regulatory warnings or label changes, and shift demand for treatments or create liability risks that influence a company\u2019s valuation.<\/p>\n
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\n 07\/24\/2026 – 07:00 AM
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Recommendation based on DESTINY-Breast09 phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years<\/p>\n
If approved, Daiichi Sankyo and AstraZeneca\u2019s Enhertu plus pertuzumab would become first new treatment in the EU in more than a decade for first-line HER2 positive metastatic breast cancer<\/p>\n
TOKYO–(BUSINESS WIRE)–
\nEnhertu\u00ae (trastuzumab deruxtecan) in combination with pertuzumab has been recommended for approval in the European Union (EU) for the first-line treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer.<\/p>\n
\nEnhertu 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\/NYSE: AZN<\/a>).<\/p>\n \nThe Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the DESTINY-Breast09<\/a> phase 3 trial presented<\/a> at the 2025 American Society of Clinical Oncology Annual Meeting and subsequently published in The New England Journal of Medicine<\/a>. The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU.<\/p>\n \nIn DESTINY-Breast09, Enhertu in combination with pertuzumab reduced the risk of disease progression or death by 44% versus a taxane, trastuzumab and pertuzumab (THP) (hazard ratio: 0.56; 95% confidence interval [CI]: 0.44-0.71; p<0.00001) in patients (n=383) with HER2 positive metastatic breast cancer who had not received prior chemotherapy or HER2 targeted therapy or had received neoadjuvant or adjuvant HER2 targeted therapy more than six months before the diagnosis of advanced or metastatic disease. Median progression-free survival (PFS) was 40.7 months (95% CI: 36.5-not estimable [NE]) with Enhertu in combination with pertuzumab compared to 26.9 months (95% CI: 21.8-NE) with THP as assessed by blinded independent central review (BICR). The PFS benefit was consistent across subgroups, including the prespecified stratification factors of hormone receptor (HR) status, de novo or recurrent disease and PIK3CA mutation status.<\/p>\n \nConfirmed objective response rate (ORR) was 85.1% (95% CI: 81.2-88.5) for Enhertu in combination with pertuzumab compared to 78.6% (95% CI: 74.1-82.5) with THP. There were 58 (15.1%) complete responses (CR) and 268 (70.0%) partial responses (PR) with Enhertu plus pertuzumab compared to 33 (8.5%) CRs and 271 (70.0%) PRs with THP. Median duration of response (DOR) for Enhertu plus pertuzumab exceeded three years (39.2 months) versus 26.4 months for THP.<\/p>\n \n\u201cEnhertu in combination with pertuzumab improved progression-free survival by more than one year compared with the current first-line standard of care, representing a meaningful advantage early in the treatment of patients with metastatic HER2 positive disease,\u201d said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. \u201cToday\u2019s positive CHMP opinion brings us closer to making Enhertu available in the EU as a first-line treatment option for eligible patients with HER2 positive metastatic breast cancer, marking an important milestone in moving this medicine earlier in the treatment pathway.\u201d<\/p>\n \n\u201cHER2 positive metastatic breast cancer is an aggressive subtype, so starting patients on an effective HER2 targeted treatment early and continuing it for as long as they benefit can have a meaningful impact on long-term outcomes,\u201d said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology Hematology R&D, AstraZeneca. \u201cDESTINY-Breast09 sets a new benchmark with a median progression-free survival of more than three years, underscoring the potential of Enhertu plus pertuzumab to redefine first-line treatment for patients with HER2 positive metastatic breast cancer.\u201d<\/p>\n \nThe safety profile of Enhertu in combination with pertuzumab in DESTINY-Breast09 was consistent with the known profiles of each individual treatment with no new safety concerns identified. The most common grade 3 or higher treatment-related adverse events that occurred in patients treated with Enhertu in combination with pertuzumab (n=381) were neutropenia (23.9%), hypokalemia (10.2%), and anemia (8.4%). Interstitial lung disease (ILD) or pneumonitis occurred in 12.1% of patients treated with Enhertu in combination with pertuzumab as determined by an independent adjudication committee. The majority of ILD or pneumonitis events were low grade (grade 1 [n=17; 4.5% or grade 2 [n=27; 7.1%]). There were two grade 5 events (0.5%) of ILD or pneumonitis in the Enhertu plus pertuzumab arm.<\/p>\n \nEnhertu (5.4 mg\/kg) in combination with pertuzumab is approved in India, Israel, Saudi Arabia, Singapore, South Korea, Switzerland, the United Arab Emirates and the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by a locally or regionally approved test, based on the results from the DESTINY-Breast09 trial.<\/p>\n \nEnhertu is also under review in the EU for patients with HER2 positive breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment based on data from the DESTINY-Breast05<\/a> trial.<\/p>\n \nAbout DESTINY-Breast09<\/p>\n \nDESTINY-Breast09<\/a> is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of Enhertu (5.4 mg\/kg) either alone or in combination with pertuzumab versus standard of care THP as first-line treatment in patients with HER2 positive metastatic breast cancer.<\/p>\n \nPatients were randomized 1:1:1 to receive either Enhertu monotherapy with a pertuzumab matching placebo; Enhertu in combination with pertuzumab; or THP. Randomization was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), HR status and PIK3CA mutation status.<\/p>\n \nThe primary endpoint of DESTINY-Breast09 is PFS as assessed by BICR in both the Enhertu monotherapy and Enhertu combination arms. Secondary endpoints include investigator-assessed PFS, overall survival, ORR, DOR, pharmacokinetics and safety. The investigational arm assessing Enhertu monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis.<\/p>\n \nDESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov<\/a>.<\/p>\n \nAbout HER2 Positive Metastatic Breast Cancer<\/p>\n \nBreast cancer is the most common cancer in women worldwide and the leading cause of cancer-related deaths among women.1 Approximately 2.4 million breast cancer cases were diagnosed in 2024, with more than 690,000 deaths globally.1 In Europe, approximately 540,000 cases of breast cancer are diagnosed annually, with more than 140,000 deaths.2 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or whose disease has progressed to metastatic disease are expected to live five years following diagnosis.3<\/p>\n \nHER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer.4 HER2 protein overexpression may occur as a result of HER2 gene amplification.4 Approximately one in five cases of breast cancer is considered HER2 positive.5<\/p>\n \nHER2 positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer.5 While HER2 targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with THP, which has been the standard of care for more than a decade.6,7,8 Further, approximately one in three patients do not receive any treatment following first-line therapy due to disease progression or death.9,10<\/p>\n \nAbout Enhertu<\/p>\n \nEnhertu (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo\u2019s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca\u2019s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.<\/p>\n \nEnhertu (5.4 mg\/kg) followed by THP is approved in China, Singapore and the U.S. as a neoadjuvant treatment for adult patients with HER2 positive (IHC 3+ or ISH+) stage 2 or stage 3 breast cancer based on the results from the DESTINY-Breast11<\/a> trial. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.<\/p>\n \nEnhertu (5.4 mg\/kg) is approved in the U.S. for the adjuvant treatment of adult patients with HER2 positive breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05<\/a> trial.<\/p>\n \nEnhertu (5.4 mg\/kg) in combination with pertuzumab is approved in India, Israel, Saudi Arabia, Singapore, South Korea, Switzerland, the United Arab Emirates and the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by a locally or regionally approved test, based on the results from the DESTINY-Breast09<\/a> trial.<\/p>\n \nEnhertu (5.4 mg\/kg) is approved in more than 100 countries\/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03<\/a> trial.<\/p>\n \nEnhertu (5.4 mg\/kg) is approved in more than 75 countries\/regions worldwide for the treatment of adult patients with unresectable or metastatic HR positive, HER2 low (IHC 1+ or IHC 2+\/ ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06<\/a> trial.<\/p>\n \nEnhertu (5.4 mg\/kg) is approved in more than 100 countries\/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+\/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04<\/a> trial.<\/p>\n \nEnhertu (5.4 mg\/kg) is approved in more than 80 countries\/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02<\/a> and\/or DESTINY-Lung05<\/a> trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.<\/p>\n \nEnhertu (6.4 mg\/kg) is approved in more than 90 countries\/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+\/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01<\/a>, DESTINY-Gastric02<\/a> and\/or DESTINY-Gastric04<\/a> trials.<\/p>\n \nEnhertu (5.4 mg\/kg) is approved in more than 45 countries\/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02<\/a>, DESTINY-Lung01<\/a>, DESTINY-CRC02<\/a> and\/or HERALD<\/a> trials. Continued approval in the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.<\/p>\n \nAbout the Enhertu Clinical Development Program<\/p>\n \nA comprehensive global clinical development program is underway evaluating the efficacy and safety of Enhertu as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers.<\/p>\n \nAbout the Daiichi Sankyo and AstraZeneca Collaboration<\/p>\n \nDaiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize Enhertu in March 2019<\/a> and Datroway\u00ae in July 2020<\/a>, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and Datroway.<\/p>\n \nAbout the ADC Portfolio of Daiichi Sankyo<\/p>\n \nThe Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo.<\/p>\n \nThe DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include Enhertu and Datroway, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo.<\/p>\n \nAn additional ADC being developed by Daiichi Sankyo is DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING.<\/p>\n \nIfinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610 and DS3790 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.<\/p>\n \nAbout Daiichi Sankyo<\/p>\n \nDaiichi Sankyo (TSE: 4568) is a global healthcare company committed to becoming a trusted healthcare innovator, transforming the lives of people through its strength in science and technology. The company discovers and develops new standards of care to address diverse medical needs to fulfill its purpose of contributing to the enrichment of quality of life around the world. With a strategic focus on oncology, Daiichi Sankyo is advancing an industry-leading antibody drug conjugate portfolio along with identifying new breakthrough generating technologies to deliver practice-changing medicines to patients, healthcare professionals and society. For more information, please visit www.daiichisankyo.com<\/a>.<\/p>\n \nREFERENCES:<\/p>\n \n1 World Health Organization. Global Status Report On Cancer 2026: The Future We Choose Together<\/a>. Accessed July 2026. View source version on businesswire.com: https:\/\/www.businesswire.com\/news\/home\/20260723402930\/en\/<\/a><\/p>\n \nMEDIA CONTACTS: \nEU: \nJapan:
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2 World Health Organization. Breast Fact Sheet<\/a>. Accessed July 2026.
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3 National Cancer Institute. SEER Cancer Stat Facts: Female Breast Cancer Subtypes<\/a>. Accessed July 2026.
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4 Cheng X. Genes<\/a> (Basel). 2024;15(7):903.
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5 Tarantino P, et al. Ann Oncol<\/a>. 2023;34(8):645-659.
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6 Swain SM, et al. Lancet Oncol<\/a>. 2020;21(4):519-530.
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7 Blumenthal G, et al. Clin Cancer Res<\/a>. 2013;19(18):4911-4916.
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8 Tripathy D, et al. Oncologist<\/a>. 2020;25(2):e214-e222.
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9 Hall PS, et al. Presented at SABCS Annual Meeting 2023.
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10 Hartkopf AD, et al. Geburtshilfe Frauenheilkd<\/a>. 2024;84(5):459-469.<\/p>\n<\/p>\n
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Global:
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Jennifer Brennan
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jennifer.brennan@daiichisankyo.com
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+ 1 908 900 3183 (mobile)<\/p>\n
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Simone Jendsch-Dow\u00e9
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simone.jendsch-dowe@daiichisankyo.com
\n<\/a>
+49 (89) 78080 (office)<\/p>\n
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DS-PR_jp@daiichisankyo.com<\/a><\/p>\n