[Breast Cancer Special Issue #60] A New Therapy for Advanced Breast Cancer! The UK–Japan Frontier Drug Dato-DXd Shrinks Tumors in 36.4% of Patients!

Recently, the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Dato-DXd—a novel antibody–drug conjugate (ADC) jointly developed by UK- and Japan-based pharmaceutical companies—for the treatment of adult patients with unresectable or metastatic hormone receptor–positive, HER2-negative breast cancer who have previously received systemic anticancer therapy. Key highlights: 1. The FDA has accepted the marketing application for Dato-DXd, with a regulatory decision expected in Q1 next year. 2. Based on currently available clinical data, Dato-DXd demonstrates superior efficacy and safety compared to conventional chemotherapy—significantly increasing its likelihood of approval. Study Details (for healthcare professionals): The BLA submission for Dato-DXd is supported by data from the Phase 3 TROPION-Breast01 trial (NCT05104866). Results showed that among 365 patients treated with Dato-DXd, median progression-free survival (PFS) was 6.9 months, versus 4.9 months among 367 patients receiving investigator-selected chemotherapy. Dato-DXd is an ADC targeting TROP2, co-developed by the global biopharmaceutical company AstraZeneca (headquartered in the UK) and Daiichi Sankyo (Japan). Notably, overall survival data remain immature at a median follow-up of 9.7 months; however, the observed benefit trend for patients treated with Dato-DXd is already clearly evident. The FDA is expected to issue its decision on approval in Q1 2025.

Weekly Global Regulatory Approvals, Licensing & Partnerships, M&A, Clinical Updates, and Financial Performance of Leading International Pharma Companies — Week of July 20–26, 2026

• AstraZeneca: On July 24, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Trixeo Aerosphere—a fixed-dose triple-combination inhaler containing budesonide/glycopyrronium/formoterol fumarate (320/28.8/9.6 µg)—for maintenance treatment of asthma in patients aged 12 years and older whose disease remains uncontrolled despite medium-dose inhaled corticosteroid (ICS) plus long-acting beta2-agonist (LABA) therapy. Trixeo Aerosphere is marketed as Breztri Aerosphere in the United States, China, and Japan. The CHMP recommendation is based on results from the Phase 3 KALOS and LOGOS trials. Compared with ICS/LABA combination therapy, Trixeo demonstrated statistically significant improvements in lung function. Across a broad patient population—including those without asthma exacerbations in the prior year—Trixeo significantly reduced the annualized rate of severe asthma exacerbations versus ICS/LABA. In a key secondary endpoint, Trixeo showed rapid onset of action, with statistically significant improvement in lung function within five minutes of the first dose. Findings from the KALOS and LOGOS studies were published in The Lancet Respiratory Medicine in February 2026. Trixeo is a single-inhaler, fixed-dose triple-combination product comprising the LABA formoterol fumarate, the long-acting muscarinic antagonist (LAMA) glycopyrronium, and the ICS budesonide, delivered via Aerosphere pressurized metered-dose inhaler (pMDI). • AstraZeneca: On July 24, the CHMP recommended approval of Enhertu (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab for first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer. The recommendation is based on results from the Phase 3 DESTINY-Breast09 trial, presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, and subsequently published in The New England Journal of Medicine. In DESTINY-Breast09, among patients with HER2-positive metastatic breast cancer who had not previously received chemotherapy or HER2-targeted therapy—or who had received neoadjuvant or adjuvant HER2-targeted therapy more than six months before diagnosis of advanced or metastatic disease—the combination of fam-trastuzumab deruxtecan-nxki and pertuzumab reduced the risk of disease progression or death by 44% versus paclitaxel plus trastuzumab and pertuzumab. Median PFS was 40.7 months in the fam-trastuzumab deruxtecan-nxki plus pertuzumab group versus 26.9 months in the control group. Enhertu is a HER2-targeting DXd antibody–drug conjugate (ADC) developed by Daiichi Sankyo and co-developed and commercialized by AstraZeneca and Daiichi Sankyo. • Gilead: On July 24, Gilead announced that the CHMP adopted a positive opinion recommending approval of Trodelvy (sacituzumab govitecan) in combination with Keytruda (pembrolizumab) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express programmed death-ligand 1 (PD-L1) with a combined positive score (CPS) ≥10, and who have not received prior systemic therapy for metastatic disease.

AstraZeneca-Daiichi breast cancer drug cleared for NHS use in England

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The UK's NICE has approved AstraZeneca and Daiichi Sankyo's breast cancer drug Enhertu for NHS use in England, expanding access to approximately 1,000 patients annually following revised cost-effectiveness guidelines.

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