WILMINGTON, DE — AstraZeneca and Daiichi Sankyo announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to their supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer.
The decision is based on results from the Phase III DESTINY-Breast09 trial, which showed the ENHERTU-plus-pertuzumab regimen reduced the risk of disease progression or death by 44% compared with the current standard of care, a taxane combined with trastuzumab and pertuzumab (THP). Median progression-free survival was more than three years with the new combination versus just under 27 months with THP.
“The trial produced a new landmark of more than 40 months for progression-free survival and nearly doubled the number of patients with no evidence of disease on imaging,” said Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca. “This marks the first major evolution in first-line treatment for HER2-positive metastatic breast cancer in over a decade.”
Ken Takeshita, Global Head of R&D at Daiichi Sankyo, added that the data show ENHERTU plus pertuzumab delayed disease progression “for more than three years compared to around two years with the current standard of care.”
The sBLA is under review through the FDA’s Real-Time Oncology Review program, which accelerates evaluation of promising cancer therapies. A regulatory decision is expected in the first quarter of 2026.
HER2-positive metastatic breast cancer, which accounts for up to 20% of metastatic breast cancer cases, remains a particularly aggressive disease. Approximately 10,000 U.S. patients are treated annually in the first-line setting.
If approved, the ENHERTU-based regimen could redefine the treatment standard, moving the therapy from second-line to first-line use and expanding access to patients earlier in their treatment journey.
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