HUTCHMED (HCM) and Innovent Biologics said Tuesday that the new drug application for the combination of ELUNATE and TYVYT has been granted conditional approval in China for the treatment of certain patients with advanced endometrial cancer.
This follows the priority review status and breakthrough therapy designation granted by the National Medical Products Administration of China.
The approval was supported by data from the phase II study, FRUSICA-1, which showed objective response rate and disease control rate of 35.6% and 88.5% respectively.
The company further said that the combination treatment showed rapid on-set efficacy, with a median time to response of 1.6 months, and median progression-free survival and overall survival of 9.5 months and 21.3 months, respectively.
The company also plans to do a phase III confirmatory study of the combination treatment.
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