The European Commission has officially granted approval for Enhertu (trastuzumab deruxtecan) as a monotherapy for the adjuvant treatment of adult patients with HER2-positive early breast cancer. This significant regulatory milestone follows a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued in September.
The approval is specifically indicated for patients who have residual invasive disease after completing both neoadjuvant taxane-based and HER2-targeted therapy. This strategic shift allows the drug, co-developed and commercialized by Daiichi Sankyo and AstraZeneca, to reach patients at a much earlier stage in their treatment journey.
The decision mirrors a landmark approval granted in the United States this past May, where regulators similarly greenlit the drug for the same adjuvant indication. Both the U.S. FDA and European authorities based their positive determinations on clinical data derived from the pivotal Phase III DESTINY-Breast05 trial. The data demonstrated that the treatment offers robust efficacy, with more than 92% of patients remaining alive and free of invasive disease at the three-year mark, suggesting that the therapy could set a new standard of care in the curative-intent setting.
Following this regulatory success, Daiichi Sankyo is set to receive a $75 million milestone payment from AstraZeneca, further cementing the financial success of their collaborative partnership, which began in March 2019.
Ken Keller, Global Head of Oncology Business and President and CEO of Daiichi Sankyo, emphasized the importance of this shift in clinical approach. “By bringing Enhertu into the adjuvant setting, we are advancing this treatment option earlier,” Keller stated. “This first approval in the EU reflects our continued commitment to bringing innovative medicines into earlier treatment settings. There is significant potential to improve long-term outcomes for patients.”
AstraZeneca’s leadership echoed this sentiment, highlighting the broader implications for the oncology community. Dave Fredrickson, Executive Vice President of the Oncology Hematology Business Unit at AstraZeneca, underscored that the primary goal in early breast cancer treatment remains achieving a long-term cure.
“Unfortunately, despite treatment advances, some patients still face recurrence in the long term,” Fredrickson said. “This approval has the potential to establish a new benchmark in this curative-intent setting.”
The move marks another chapter in the rapid expansion of Enhertu’s label, which has become a cornerstone of both companies’ oncology portfolios. As the therapy moves from late-stage metastatic treatment into earlier, adjuvant settings, clinicians and patients alike are hopeful that the drug’s performance in the DESTINY-Breast05 trial will translate into sustained, disease-free survival for thousands across the European Union.
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