On December 3, 2024, Hutchmed announced that its self-developed innovative drug Fuguetinib has been approved by the National Medical Products Administration (NMPA) of China. This drug is to be used in combination with Sintilimab for patients with advanced mismatch repair-proficient (pMMR) endometrial cancer (EMC) who have failed previous systemic anti-tumor therapies and are not suitable for radical surgical treatment or radical radiotherapy. This approval marks the first and only selective inhibitor targeting three VEGFR subtypes in China, granted approval for the treatment of colorectal cancer in the key markets of the U.S., Europe, and Japan in over a decade. In 2024, Fuguetinib, in combination with Sintilimab, received a new indication through the NMPA's priority review.

Currently, traditional treatment for advanced endometrial cancer primarily focuses on surgical intervention, supplemented by systemic treatments such as radiotherapy, chemotherapy, or hormone therapy. For patients who are not suitable candidates for radical surgery, particularly those whose disease continues to progress after systemic therapy, treatment options are quite limited. This novel combination opens up new therapeutic strategies for the treatment of advanced endometrial cancer (EMC).

The approval of Fuguetinib in China is primarily based on data from the FRUSICA-1 study. FRUSICA-1 is a multicenter, open-label Phase II registration cohort study designed to evaluate the efficacy of the combination of Fuguetinib and Sintilimab (known as the "Happy" combination) in treating endometrial cancer patients who have experienced disease recurrence, progression, or intolerable toxicity following platinum-based doublet chemotherapy.

Professor Wu Xiaohua, director of the Gynecology Oncology Department at the Fudan University Shanghai Cancer Center and the principal investigator of the FRUSICA-1 study, stated: "The approval of the combination therapy of Fuguetinib and Sintilimab is a significant innovation that not only leverages the synergistic effects of targeted therapy and immunotherapy but is also expected to fill the gaps in the treatment of patients with poor responses to traditional therapies. This combination has demonstrated a certain level of efficacy and safety in clinical trials, and we look forward to providing this treatment option for patients."

Industry experts believe that with the widespread application of the Fuguetinib and Sintilimab therapy, there is hope for significantly advancing the precision treatment and comprehensive management of endometrial cancer (EMC) in China.

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