Hutchmed, Innovent jointly announce NDA acceptance in China

HUTCHMED (HCM) and Innovent Biologics “jointly announce that the New Drug Application for the combination of fruquintinib and sintilimab for the treatment of patients with locally advanced or metastatic renal cell carcinoma who have failed prior treatment with one tyrosine kinase inhibitor has been accepted for review by the China National Medical Products Administration. The NDA is supported by data from FRUSICA-2, a randomized, open-label, active-controlled registration study evaluating the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy for the second-line treatment of advanced renal cell carcinoma. The study has met its primary endpoint of progression free survival, as assessed by blinded independent central review according to RECIST 1.1 criteria. The combination also demonstrated improvements in secondary endpoints including objective response rate and duration of response. The safety profile was tolerable and no new safety signals were observed. Data from FRUSICA-2 will be submitted for presentation at an upcoming scientific conference.”