AstraZeneca secured FDA approval for its antibody‑drug conjugate ENHERTU (fam‑trastuzumab deruxtecan‑nxki) in combination with pertuzumab as a first‑line therapy for adult patients with unresectable or metastatic HER2‑positive breast cancer. The approval, granted on December 15, 2025, follows the company’s DESTINY‑Breast09 Phase III trial.
The trial demonstrated a 44 % reduction in the risk of disease progression or death compared with the standard taxane‑trastuzumab‑pertuzumab (THP) regimen. Median progression‑free survival reached 40.7 months for the ENHERTU‑plus‑pertuzumab arm versus 26.9 months for THP, confirming the combination’s superior efficacy in the first‑line setting.
The approval expands ENHERTU’s addressable market to the largest patient cohort in HER2‑positive breast cancer and is expected to add $2 billion to $3 billion to peak sales, according to analysts at Jefferies. It also triggers a $150 million milestone payment to Daiichi Sankyo under the joint‑development agreement, reinforcing the partnership that underpins the drug’s commercialization.
Executive Vice President Dave Fredrickson said the first‑line indication “sets a new benchmark of more than three years without disease progression or death for patients in this setting.” Oncology leader Sara Tolaney highlighted that the combination is the only first‑line therapy in more than a decade to demonstrate a statistically significant improvement in progression‑free survival, positioning ENHERTU as a potential new standard of care.
Analysts noted that the approval aligns with AstraZeneca’s FY 2025 guidance, which projects high‑single‑digit revenue growth and a low‑double‑digit core earnings‑per‑share increase. The milestone payment and expanded market share are seen as key drivers of the company’s continued momentum in oncology.
The FDA approval marks a pivotal regulatory milestone for AstraZeneca’s oncology portfolio, solidifying ENHERTU’s role as a leading therapy for HER2‑positive metastatic breast cancer and setting the stage for further growth in the company’s high‑margin oncology segment.
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