RemeGen’s Disitamab vedotin gains approval in China for its third indication making it the first ADC approved for HER2-positive advanced Breast cancer with liver metastasis globally

CAR-T Digest - August 2020

Weekly Digest - May 2025

09 May 2025: RemeGen’s Disitamab vedotin gains approval in China for its third indication making it the first ADC approved for HER2-positive advanced Breast cancer with liver metastasis globally

China’s National Medical Products Administration (NMPA) approved Disitamab vedotin (Aidixi) for HER2-positive advanced breast cancer with liver metastasis (BCLM) in patients previously treated with trastuzumab or its biosimilars and taxanes
The approval is based on the Phase 3 RC48-C006 study a randomized, open-label, multicenter trial comparing DV to lapatinib plus capecitabine in 104 patients with HER2-positive advanced BCLM
Aidixi significantly improved progression-free survival (PFS), with a median of months compared to 9 months for the standard regimen (hazard ratio [HR] = 0.56; 95% confidence interval [CI]: 0.35–0.90)
DV demonstrated a manageable safety profile consistent with previous use, with no new safety signals detected
Approximately 45% of patients with HER2-positive advanced Breast cancer develop liver metastases, a subset with a poor prognosis and a 5-year survival rate of only 8% to 12%. Prior to this approval, no satisfactory therapies were available for this group