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(Sharecast News) - Hutchmed China and its partner Innovent Biologics announced conditional approval from China's National Medical Products Administration (NMPA) for the combination of 'Elunate', or fruquintinib, and 'Tyvyt', or sintilimab injection, to treat advanced endometrial cancer with mismatch repair proficient (pMMR) tumours.
The AIM-traded pharmaceutical developer said it was the first regulatory approval for combining fruquintinib, a VEGFR inhibitor, with a leading immune checkpoint inhibitor.
It said the approval, granted under priority review and breakthrough therapy designation, was based on results from the FRUSICA-1 phase two study.
The trial showed an objective response rate of 35.6% and a disease control rate of 88.5%, with a median progression-free survival of 9.5 months and overall survival of 21.3 months.
Adverse events were consistent with similar immunotherapy and antiangiogenic combinations.
The firm said the combination therapy would address a critical unmet need for patients whose disease had progressed following platinum-based chemotherapy and were not candidates for curative surgery or radiation.
A phase three confirmatory study was planned to further validate the results.
Hutchmed said the milestone built on fruquintinib's established global approvals, including in the US, EU, and other major markets, and sintilimab's extensive indications in China, which now included advanced endometrial cancer.
Both drugs had demonstrated robust efficacy and safety profiles, it noted.
"This NMPA approval of fruquintinib in combination with sintilimab represents a significant advancement for patients with advanced endometrial cancer who have long awaited more effective treatments. It underscores the potential of fruquintinib to be used with other therapeutic agents to improve patient outcomes," Hutchmed's head of research and development and chief medical officer Dr Michael Shi.
"It is also a testament to our ongoing efforts to extend the clinical benefit of fruquintinib to a broader patient population.
"We are eager to make this innovative treatment available to advanced endometrial cancer patients as soon as we can and will continue to explore further opportunities to bring hope to more patients battling cancer."
At 1004 GMT, shares in Hutchmed China were down 2.86% at 272p.
Reporting by Josh White for Sharecast.com.
