HUTCHMED and Innovent Jointly Announce NMPA Conditional Approval for ELUNATE® (Fruquintinib) in Combination with TYVYT® (Sintilimab Injection) for the Treatment of Advanced Endometrial Cancer

Core Insights - The New Drug Application for the combination of fruquintinib and sintilimab has received conditional approval in China for treating advanced endometrial cancer patients with pMMR tumors who have failed prior systemic therapy and are not candidates for curative surgery or radiation [1][2][3] Company Insights - HUTCHMED and Innovent Biologics are collaborating on the development of fruquintinib and sintilimab, with HUTCHMED focusing on extending the clinical benefits of fruquintinib to a broader patient population [3][15] - Innovent aims to provide innovative treatment options that improve survival rates and quality of life for patients with advanced endometrial cancer [3][16] Clinical Study Insights - The approval was supported by data from the FRUSICA-1 study, which showed an objective response rate (ORR) of 35.6% and a disease control rate (DCR) of 88.5% for the combination therapy [2] - The median progression-free survival (PFS) and overall survival (OS) were reported at 9.5 months and 21.3 months respectively, indicating promising efficacy [2][3] Market Context - Endometrial cancer remains a significant global health challenge, with approximately 417,000 diagnoses and around 97,000 deaths reported in 2020 [6] - In China, there were an estimated 82,000 new cases of endometrial cancer in 2020, highlighting the unmet need for effective treatments in this area [6] Product Insights - Fruquintinib is a selective oral inhibitor of all three VEGF receptors, designed to inhibit tumor angiogenesis and enhance selectivity [7] - Sintilimab, marketed as TYVYT®, is a PD-1 monoclonal antibody that reactivates T-cells to kill cancer cells and has multiple approved indications in China [11][12]