HUTCHMED and Innovent Announce NDA Acceptance in China for Fruquintinib–Sintilimab Combination in Advanced Renal Cell Carcinoma
Friday, June 06, 2025
HUTCHMED and Innovent Biologics have jointly announced that the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for the combination of fruquintinib and sintilimab.
Globally, kidney cancer affected around 435,000 individuals in 2022, with China accounting for approximately 74,000 of those cases. Renal cell carcinoma represents the most common type, comprising nearly 90% of kidney cancer diagnoses.
Monotherapy remains a standard first-line treatment for advanced RCC in China. However, patients who do not respond to initial treatments have limited options. A Phase Ib/II study evaluating the fruquintinib–sintilimab combination in this setting showed encouraging results, including a 60% objective response rate and a median progression-free survival of 15.9 months. Median overall survival was not reached at the time of data cut-off, and the treatment was generally well tolerated.
The application seeks approval for the treatment of patients with locally advanced or metastatic renal cell carcinoma (RCC) who have previously been treated with a tyrosine kinase inhibitor (TKI).
The NDA is supported by results from the FRUSICA-2 study, which compared the combination of fruquintinib and sintilimab with monotherapy using either axitinib or everolimus. The study met its primary endpoint of progression-free survival, with additional improvements observed in response rate and duration of response. The safety profile remained consistent with no new safety concerns reported. Further results from the study are expected to be shared at an upcoming scientific meeting.
Renal cell carcinoma remains a significant health burden in China, especially among patients who do not respond to first-line therapies. The NDA for this combination therapy is seen as a step forward in addressing this treatment gap.
This submission also represents the tenth indication under review for sintilimab, underlining its growing role in immuno-oncology.
Source: hutch-med.com
