Hutchmed (China) Limited and Innovent Biologics Inc. have announced that the China National Medical Products Administration (NMPA) has not only accepted but also granted a priority review for the New Drug Application (NDA) for a drug cocktail of fruquintinib and sintilimab. This application is specifically intended for the administration of patients dealing with advanced endometrial cancer with either non-MSI-H or pMMR tumors. This particular treatment plan is for those patients who have not responded to earlier systemic therapy and are not suitable candidates for curative surgery or radiation.
The entities also indicated the NMPA's approval of the Breakthrough Therapy designation for the combination therapy in July 2023. This designation was given to the treatment combination because it presents a new way to target a severe illness that lacks effective therapeutic options currently available. Furthermore, clinical findings reveal that it holds significant advantages over existing therapies.
Endometrial cancer begins in the uterus, and in 2020 alone, this disease was responsible for approximately 97,000 deaths and affected an estimated 417,000 people worldwide.
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