HUTCHMED and INNOVENT BIO announced: The new drug application for furmonertinib combined with sintilimab for the treatment of advanced renal cell carcinoma in China has been accepted
HUTCHMED and INNOVENT BIO jointly announced that the new drug application for the combination therapy of furmonertinib and sintilimab for the treatment of advanced renal cell carcinoma has been accepted by the National Medical Products Administration of China. This therapy targets patients who have previously failed treatment with a tyrosine kinase inhibitor. The FRUSICA-2 study data supports the application, demonstrating good efficacy and safety. HUTCHMED stated that this application is an important step in addressing the unmet medical needs of kidney cancer patients
According to the Zhitong Finance APP, Hutchmed China (00013) and Innovent Bio (01801) jointly announced that the new drug application for the combination therapy of fruquintinib and sintilimab for the treatment of locally advanced or metastatic renal cell carcinoma patients who have previously failed treatment with a tyrosine kinase inhibitor has been accepted by the National Medical Products Administration of China (NMPA).
Data from the FRUSICA-2 study supports this new drug application. FRUSICA-2 is a randomized, open-label, positive-controlled registration study designed to evaluate the efficacy and safety of the combination therapy of fruquintinib and sintilimab compared to monotherapy with axitinib or everolimus for second-line treatment of advanced renal cell carcinoma. The study has achieved its primary endpoint of progression-free survival (PFS) assessed by blinded independent central review (BICR) according to RECIST 1.1 criteria. The combination therapy also showed improvements in secondary endpoints, including objective response rate (ORR) and duration of response (DoR). The safety profile is tolerable, and no new safety signals were observed. Data from the FRUSICA-2 study will be presented at an upcoming academic conference. Further details of the study can be found on clinicaltrials.gov, with the registration number NCT05522231.
Dr. Shi Ming, Head of R&D and Chief Medical Officer of Hutchmed China, stated: "Renal cancer remains a significant challenge in China, and treatment options are very limited for patients who have failed first-line therapy. The submission of the new drug application for the combination of fruquintinib and sintilimab for advanced renal cell carcinoma is an important step in addressing this unmet medical need. We are committed to making this combination therapy available to renal cell carcinoma patients. At the same time, we will continue to research to explore the greater potential of this combination therapy and advance the application of other products in our pipeline across multiple cancer fields, providing innovative and effective treatment options for more patients."
Dr. Zhou Hui, Senior Vice President of Innovent Bio, expressed: "We are pleased to see the second new drug application for the combination of sintilimab and fruquintinib accepted, which is expected to provide a more effective second-line treatment option for advanced renal cell carcinoma patients in China. This is also the 10th accepted new drug application for sintilimab (Daboshu®), further consolidating its leading position as a cornerstone drug in immuno-oncology (IO) treatment, and represents an important milestone for Innovent Bio in lifecycle management and maximizing its clinical value."
The combination therapy of fruquintinib and sintilimab received conditional approval from the NMPA in December 2024 for the treatment of advanced mismatch repair proficient (pMMR) endometrial cancer patients who have failed previous systemic anti-tumor therapy and are not suitable for curative surgical treatment or radical radiotherapy. This approval is based on data from the FRUSICA-1 study (NCT03903705)
