HUTCHMED: The new drug application for the combination therapy of Roflumilast and Sintilimab has been accepted

HUTCHMED (00013.HK) announced the results of the FRUSICA-2 registration study of fruquintinib in combination with sintilimab for the treatment of patients with locally advanced or metastatic renal cell carcinoma. The results of the Phase III portion of the study will be presented on October 17 at the European Society for Medical Oncology (ESMO) annual meeting in Berlin, Germany.

The company stated that based on the data from the FRUSICA-2 study, the National Medical Products Administration of China has accepted the new drug application for the combination therapy of fruquintinib and sintilimab for patients with locally advanced or metastatic renal cell carcinoma who have previously failed systemic therapy.

Currently, fruquintinib has been approved in China for use in patients who have previously received fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, as well as for patients with metastatic colorectal cancer who have previously received or are unsuitable for anti-vascular endothelial growth factor (VEGF) therapy and anti-epidermal growth factor receptor (EGFR) therapy (RAS wild-type). The combination therapy of fruquintinib and sintilimab has been conditionally approved in China for patients with advanced mismatch repair proficient (pMMR) endometrial cancer who have failed previous systemic anti-tumor therapy and are unsuitable for curative surgical treatment or radical radiotherapy