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HUTCHMED: ELUNATE and TYVYT Combination Therapy Approved by NMPA for Advanced or Metastatic Renal Cell Carcinoma
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HUTCHMED (00013.HK) and INNOVENT BIO (01801.HK) jointly announced that the New Drug Application (NDA) for the combination of ELUNATE (fruquintinib) and TYVYT (sintilimab injection) has been granted approval by the China National Medical Products Administration (NMPA) for the treatment of patients with locally advanced or metastatic renal cell carcinoma who have failed prior vascular endothelial growth factor receptor-tyrosine kinase inhibitors (VEGFR-TKI) therapy and have not received programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor therapy in the first-line setting. The approval 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 patients with locally advanced or metastatic renal cell carcinoma. The study met its primary endpoint of progression free survival (PFS) as assessed by blinded independent central review (BICR). Auto-translated by AI This article was automatically translated by AI, the original language version should be considered the authoritative version. AASTOCKS.com Limited does not guarantee its accuracy or completeness and accepts no liability for any damages or losses arising from the use of this translation. More Details
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