The drug is intended for the treatment of advanced endometrial cancer and the news carries significant weight as it comes with Priority Review status, underscoring the potential impact of this therapeutic approach in addressing a critical medical need. “This is the first regulatory filing for the combination of fruquintinib and the immune checkpoint inhibitor sintilimab. It also represents an important step closer to reshaping the treatment landscape for this challenging disease in China,” said Dr Michael Shi, head of R&D and chief medical officer of HUTCHMED. googletag.cmd.push(function () {
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“TYVYT (sintilimab injection), as a backbone therapy in immuno-oncology, in combination with an anti-angiogenetic drug, may improve the prognosis for endometrial cancer patients in China,” said Dr. Hui Zhou, senior vice president of Innovent. “We are excited about the NDA acceptance and priority review designation, which increases our potential to bring a new treatment option to endometrial cancer patients, and concurrently strengthens the leadership position of TYVYT in China.” The Priority Review designation granted to the NDA underscores the regulatory recognition of the urgent medical need for effective therapies in advanced endometrial cancer. It also reflects the promising clinical data supporting the safety and efficacy of the Fruquintinib-Sintilimab combination, which has demonstrated encouraging results in clinical trials. The acceptance of the NDA marks a pivotal moment in the journey towards providing patients with advanced endometrial cancer access to a promising new treatment option. Both HUTCHMED and Innovent remain committed to advancing the development and regulatory review process, with the ultimate goal of improving outcomes and quality of life for patients battling this devastating disease.