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(Sharecast News) - Hutchmed China and Innovent Biologics announced on Thursday that China's National Medical Products Administration had accepted a new drug application for a combination therapy using fruquintinib and sintilimab to treat advanced renal cell carcinoma in patients who have failed prior tyrosine kinase inhibitor treatment.
The AIM-traded firm said the application was based on results from the FRUSICA-2 study, which met its primary endpoint of progression-free survival in a head-to-head trial against monotherapy options axitinib and everolimus.
It said he combination also showed improvements in secondary endpoints, including objective response rate and duration of response.
No new safety concerns were reported.
Fruquintinib is a VEGFR inhibitor developed by HUTCHMED, while sintilimab is a PD-1 inhibitor co-developed by Innovent and Eli Lilly.
The combination therapy previously received conditional approval in December in China for use in advanced endometrial cancer based on the FRUSICA-1 study.
Further data from FRUSICA-2 would be presented at an upcoming scientific conference, Hutchmed said.
"Kidney cancer continues to pose significant challenges in China, with limited treatment options for patients who fail first-line therapies," said Hutchmed head of research and development and chief medical officer Dr Michael Shi.
"Submitting this NDA for the fruquintinib and sintilimab combination for advanced renal cell carcinoma marks an important step in our efforts to address this unmet need."
Dr Shi said the company was dedicated to making the combination therapy available to patients with renal cell carcinoma.
"At the same time, through ongoing research, we remain focused on exploring the full potential of this combination, as well as advancing our broader pipeline across multiple cancer types, to provide more patients with new and effective treatment options."
At 1047 BST, shares in Hutchmed China were up 0.89% at 226p.
Reporting by Josh White for Sharecast.com.
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