On December 3, 2024, hutchmed (china) and innovent bio announced that their combination therapy Ai You Te® (furmonertinib) and Da Bo Shu® (sindilizumab) received conditional approval from the National Medical Products Administration of china for the treatment of patients with advanced endometrial cancer. This marks the first regulatory registration approval for the combination of furmonertinib and immuno-checkpoint inhibitors. The approval is based on data from the FRUSICA-1 study, which showed an objective response rate of 35.6% and a disease control rate of 88.5%. The FRUSICA-1 study is a multicenter, open-label phase II clinical trial designed to evaluate the efficacy of furmonertinib combined with sindilizumab in the treatment of endometrial cancer. The results showed that this combination therapy acts quickly, with a median...Show More

On December 3, 2024, hutchmed (china) and innovent bio announced that their combination therapy Ai You Te® (furmonertinib) and Da Bo Shu® (sindilizumab) received conditional approval from the National Medical Products Administration of china for the treatment of patients with advanced endometrial cancer. This marks the first regulatory registration approval for the combination of furmonertinib and immuno-checkpoint inhibitors. The approval is based on data from the FRUSICA-1 study, which showed an objective response rate of 35.6% and a disease control rate of 88.5%. The FRUSICA-1 study is a multicenter, open-label phase II clinical trial designed to evaluate the efficacy of furmonertinib combined with sindilizumab in the treatment of endometrial cancer. The results showed that this combination therapy acts quickly, with a median time to disease remission of only 1.6 months, a median progression-free survival of 9.5 months, and a median overall survival of 21.3 months. This approval represents an important advancement in the field of treatment for advanced endometrial cancer. Dr. Shi Ming, head of R&D at hutchmed (china), stated that this approval represents a significant advancement for patients with advanced endometrial cancer, highlighting the potential of furmonertinib combined with other medications to improve treatment outcomes for patients. Dr. Zhou Hui, senior vice president of innovent bio, also mentioned that the approval of this combination therapy brings new hope to patients with limited treatment options.