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Innovent and HUTCHMED Make History with NMPA Approval for Advanced Kidney Cancer Treatment

In a landmark announcement, Innovent Biologics, Inc. and HUTCHMED (China) Limited have confirmed that their joint venture has received approval from the China National Medical Products Administration (NMPA) for the combination therapy of TYVYT® (sintilimab injection) and ELUNATE® (fruquintinib). This approval is a critical moment for patients battling locally advanced or metastatic renal cell carcinoma who have not responded to previous vascular endothelial growth factor receptor-tyrosine kinase inhibitors (VEGFR-TKIs) therapy.

The combination therapy was evaluated in the FRUSICA-2 registration study. The randomized and open-label investigation focused on the efficacy of sintilimab combined with fruquintinib compared to standard axitinib or everolimus treatments in the second-line setting. Results indicated a significant reduction in disease progression or death, showcasing a median progression-free survival (PFS) of 22.2 months. This result has transformed the outlook for patients facing advanced stages of renal cancer, as conventional treatment options are often limited.

Significance of the Approval

According to Professor Dingwei Ye, a leading researcher from Fudan University Shanghai Cancer Center, this approval signifies a major advancement in how kidney cancer treatments can be tailored to meet the specific needs of patients. The combination therapy could substantially change treatment strategies for those who have explored standard options yet still face challenges.