Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276), based in China, has announced that its market approval filing for the programmed death-1 (PD-1) monoclonal antibody camrelizumab, in combination with multi-kinase inhibitor famitinib for recurrent or metastatic cervical cancer, has been accepted for review by the National Medical Products Administration (NMPA). This drug combination is intended for second-line use in patients who have not responded to platinum-containing chemotherapy.
The filing is supported by data from a randomized, open-label, controlled Phase II study that evaluated the efficacy and safety of the camrelizumab-famitinib combination against camrelizumab monotherapy and investigator-selected chemotherapy. Results indicate that the combination significantly enhances the objective response rate compared to camrelizumab alone, demonstrating a rapid onset of action, sustainable response, and an extension of overall survival for patients with recurrent and metastatic cervical cancer.
Camrelizumab was first approved in China in May 2019 for third-line treatment of classic Hodgkin’s lymphoma and has since garnered nine indication approvals across various cancers, including lung, liver, esophageal, nasopharyngeal carcinoma, and lymphoma. The combination of camrelizumab and famitinib is currently being explored in multiple clinical studies targeting non-small cell lung cancer and urological and gynecological tumors.- Flcube.com
