China’s National Medical Products Administration has granted conditional approval to a new pre-surgery treatment for adults with HER2-positive stage II or III breast cancer. The regimen uses trastuzumab deruxtecan followed by a combination of paclitaxel, trastuzumab, and pertuzumab, marking the first time this drug has been approved globally in the neoadjuvant setting.
The decision is based on results from the DESTINY-Breast11 Phase 3 trial, where the new regimen showed stronger effectiveness than standard chemotherapy. About 67.3% of patients achieved complete disappearance of detectable cancer in tissue samples, compared to 56.3% with standard treatment. The benefit was seen across different patient groups, including both hormone receptor-positive and negative cases. Early results also suggest improved long-term outcomes, though further studies are ongoing.
Side effects were consistent with previous studies, with common severe events including low white blood cell counts, diarrhea, and increased liver enzymes. A rare but serious risk of lung disease was also observed. This approval represents the seventh for trastuzumab deruxtecan in China within three years, reflecting its growing role in breast cancer treatment. Meanwhile, the U.S. Food and Drug Administration is reviewing the same regimen for potential approval in the United States.