HUTCHMED (China) Limited (HCM) and Innovent Biologics Inc. said that the China National Medical Products Administration or "NMPA" has accepted and granted priority review to the New Drug Application or "NDA" for the combination of fruquintinib and sintilimab. This application pertains to the treatment of patients with advanced endometrial cancer with pMMR or non-MSI-H tumors that have failed prior systemic therapy but are not candidates for curative surgery or radiation.
The companies noted that the NMPA granted Breakthrough Therapy designation to the combination of fruquintinib and sintilimab for this potential indication in July 2023. The NMPA granted the designation to this combination as a new treatment that could target a serious condition for which there are no effective treatment options, and where clinical evidence demonstrates substantial advantages over existing therapies.
Endometrial cancer is a type of cancer that begins in the uterus. Globally, an estimated 417,000 people were diagnosed with endometrial cancer and it caused approximately 97,000 deaths in 2020.
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