NMPA Approves New Indication for Disitamab Vedotin in HER2-Low Breast Cancer with Liver Metastases

Recently, the National Medical Products Administration (NMPA) approved a new indication for the antibody-drug conjugate (ADC) Disitamab vedotin for the treatment of adult breast cancer patients with unresectable or metastatic HER2-low expression (IHC 1+ or IHC 2+/ISH-) and liver metastases, who have previously received at least one systemic therapy in the metastatic setting, or have relapsed during or within 12 months of completing adjuvant chemotherapy.

This marks the fourth approved indication for Disitamab vedotin in China, following its previous approvals for gastric cancer, urothelial carcinoma, and HER2-positive advanced breast cancer with liver metastases.

The clinical evidence supporting this new indication is based on a randomized, open-label, parallel-controlled, multicenter Phase III clinical trial (RC48-C012) conducted in China. The study demonstrated favorable efficacy and safety of Disitamab vedotin in the treatment of adult breast cancer patients with unresectable or metastatic HER2-low expression (IHC 1+ or IHC 2+/ISH-) and liver metastases, who had previously received at least one systemic therapy in the metastatic setting, or had relapsed during or within 12 months of completing adjuvant chemotherapy.

If you or your family member are facing such a diagnosis and wish to learn about the latest treatment options, the International Department of Beijing South Region Oncology Hospital is dedicated to providing global patients with advanced medical services and multidisciplinary care that align with international standards. Our team can assist you in accessing cutting-edge therapies and connecting with leading specialists, ensuring a professional, convenient, and personalized medical experience in China.

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No matter where you are, the International Department of Beijing South Region Oncology Hospital serves as a solid bridge for you to access high-quality medical resources across borders. Let us work together to turn cutting-edge medical advancements into renewed hope for your life.

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Post time: Mar-24-2026