As reported on BioPharmaDive, the U.S. Food and Drug Administration (FDA) has granted early approval for a new frontline treatment option for HER2-positive metastatic breast cancer. The regimen combines AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu with Roche’s targeted therapy Perjeta (pertuzumab), marking a significant shift in the standard of care.
Previously, the first-line approach for these patients relied on a combination of chemotherapy and targeted drugs known as THP. However, data published in the New England Journal of Medicine demonstrated that the Enhertu-Perjeta pairing reduced the risk of disease progression or death by 44% compared to THP. Patients receiving the new regimen experienced a median progression-free survival of nearly 41 months, versus 27 months for the traditional therapy.
Enhertu, which targets the HER2 protein found in 15–20% of breast cancers, has already transformed treatment strategies since its initial approval in 2019. The drug generated $3.8 billion in sales in 2024 and is expected to grow further as it moves into earlier stages of care. AstraZeneca estimates that approximately 10,000 U.S. patients are treated annually in the first-line setting.
Safety findings were consistent with known profiles of the individual drugs, though Enhertu carries a boxed warning for interstitial lung disease and pneumonitis. In the pivotal Phase 3 trial of 1,157 participants, 46 cases of these complications occurred in the Enhertu group, including two fatalities.
The approval also triggers a $150 million milestone payment from AstraZeneca to Daiichi Sankyo, underscoring the commercial and clinical significance of this decision.
