HUTCHMED (China) Limited and Innovent Biologics, Inc. have jointly announced the acceptance of their New Drug Application (NDA) by the China National Medical Products Administration (NMPA). The application is for the combination of fruquintinib and sintilimab for the treatment of patients with advanced renal cell carcinoma who have not responded to prior treatment with a tyrosine kinase inhibitor. This NDA is backed by data from the FRUSICA-2 study, which demonstrated the efficacy and safety of the drug combination compared to monotherapy options. The announcement underscores both companies' commitment to advancing cancer therapies and enhancing treatment options for patients.
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