HUTCHMED's NDA For Fruquintinib-sintilimab Combo In Renal Cancer Accepted By China's NMPA

(RTTNews) - HUTCHMED (China) Limited (HCM) and Innovent Biologics, Inc. announced that the New Drug Application (NDA) 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 (TKI) has been accepted for review by the China National Medical Products Administration (NMPA).

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.

In December 2024, the combination of fruquintinib and sintilimab received conditional approval from the China NMPA for the treatment of patients with advanced mismatch repair proficient (pMMR) endometrial cancer who have failed prior systemic therapy and are not candidates for curative surgery or radiation, based on data from the FRUSICA-1 study.

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