China FDA accepts Hutchmed, Innovent's kidney cancer drug

Hutchmed and Innovent announced that China's National Medical Products Administration has accepted their new drug application for fruquintinib combined with sintilimab to treat advanced renal cell carcinoma. This is for patients who have previously failed tyrosine kinase inhibitor treatment. The application is supported by data from the FRUSICA-2 study, which evaluated the combination therapy against axitinib or everolimus. The study met its primary endpoint of progression-free survival, with improvements in secondary endpoints and a tolerable safety profile. This marks the second new drug application for the fruquintinib and sintilimab combination. The companies are committed to providing innovative treatment options for cancer patients and plan to present FRUSICA-2 study data at an upcoming conference.