NMPA Approval of ELUNATE® and TYVYT® Combination for Renal Cell Carcinoma

HUTCHMED and Innovent Biologics announced that the China National Medical Products Administration (NMPA) has approved the combination of ELUNATE® (fruquintinib) and TYVYT® (sintilimab injection) for the treatment of patients with locally advanced or metastatic renal cell carcinoma (RCC) who have failed prior vascular endothelial growth factor receptor-tyrosine kinase inhibitors (VEGFR-TKI) therapy and have not received programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor therapy in the first-line setting. This approval is based on the FRUSICA-2 study, which demonstrated a significant improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 63% with a median PFS of 22.2 months. The combination showed a higher objective response rate (ORR) of 60.5% compared to 24.3% with existing treatments. This marks a significant advancement in treating advanced RCC in China, addressing a critical unmet medical need.