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(Sharecast News) - Hutchmed China announced the acceptance and granting of priority review by the China National Medical Products Administration (NMPA) for a new drug application combining fruquintinib and sintilimab for the treatment of advanced endometrial cancer on Tuesday.
The AIM-traded firm said the indication, applied for in conjunction with Innovent Biologics, targets tumours that had failed prior systemic therapy but were not eligible for curative surgery or radiation.
It said the application was supported by data from the FRUSICA-1 study, a phase two investigation of the combination in patients with recurrent, progressing, or intolerant endometrial cancer following platinum-based doublet chemotherapy.
The board said the primary endpoint of FRUSICA-1 was the objective response rate (ORR), assessed by an independent review committee (IRC), with secondary endpoints including disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and pharmacokinetic (PK) assessments.
Data from the study would be presented at an upcoming medical conference, and had been registered on clinicaltrials.gov.
The NMPA granted breakthrough therapy designation to the fruquintinib and sintilimab combination in July last year, acknowledging its potential to address a serious condition with limited treatment options, backed by substantial clinical evidence of advantages over existing therapies.
"This is the first regulatory filing for the combination of fruquintinib and the immune checkpoint inhibitor sintilimab," said Dr Michael Shi, head of research and development and chief medical officer at Hutchmed.
"It also represents an important step closer to reshaping the treatment landscape for this challenging disease in China.
"Endometrial cancer remains one of the most common gynaecological malignancies; we look forward to bringing this much-awaited treatment advancement to endometrial cancer patients to improve their treatment outcome."
At 1144 GMT, shares in Hutchmed China were down 0.56% at 266p.
Reporting by Josh White for Sharecast.com.
