Hutchmed (China) (HKG:0013) and Іnnovent Biologics (HKG:1801) said the new drug application for ELUNATE (fruquintinib) in combination with TYVYT (sintilimab injection) was granted conditional approval in China for the treatment of endometrial cancer with mismatch repair proficient tumors.
The combination had previously been awarded priority review status and breakthrough therapy designation by the National Medical Products Administration of China, a Tuesday Hong Kong bourse filing said.
The approval followed the results of a phase 2 clinical study of the combination which showed objective response rate and disease control rate of 35.6% and 88.5% respectively while the adverse events are similar to that of alike immunotherapy and antiangiogenic agents combination treatments.
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