RegulatoryMay 21, 2026, 06:02 AM
HUTCHMED & Innovent get NMPA approval for ELUNATE®/TYVYT® combo
AI Summary
HUTCHMED (China) Ltd and Innovent Biologics, Inc. jointly announced that the China NMPA has approved the New Drug Application for the combination of ELUNATE® (fruquintinib) and TYVYT® (sintilimab injection). This approval is for the second-line treatment of patients with locally advanced or metastatic renal cell carcinoma who have failed prior VEGFR-TKI therapy and have not received PD-1 or PD-L1 inhibitor therapy in the first-line setting. The decision is based on compelling data from the FRUSICA-2 study, which demonstrated significant improvements in progression-free survival, objective response rate, and duration of response for the combination therapy.
Key Highlights
- NMPA approved ELUNATE® (fruquintinib) + TYVYT® (sintilimab) combo for advanced renal cell carcinoma.
- Indication: second-line treatment for locally advanced/metastatic RCC after VEGFR-TKI failure.
- Approval supported by Phase III FRUSICA-2 study data.
- FRUSICA-2 met primary endpoint of progression-free survival (PFS).
- Median PFS was 22.2 months for combo vs 6.9 months for control (HR 0.373; p<0.0001).
- Objective Response Rate (ORR) was 60.5% for combo vs 24.3% for control (p<0.0001).
- Median Duration of Response (DoR) was 23.7 months for combo vs 11.3 months for control.
- This marks the 10th approved indication for sintilimab (TYVYT®).
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