BEIJING (dpa-AFX) - Innovent Biologics Inc. and HUTCHMED (China) Limited (HCM) announced that the New Drug Application for the combination of TYVYT (sintilimab injection) and ELUNATE (fruquintinib) has received conditional approval in China. This approval is for the treatment of patients with advanced endometrial cancer who have Mismatch Repair proficient (pMMR) tumors, have failed previous systemic therapies, and are not candidates for curative surgery or radiation.
The approval follows the priority review status and breakthrough therapy designation by the National Medical Products Administration (NMPA) of China and marks the eighth approved indication for TYVYT (sintilimab injection).
The conditional approval by the NMPA was supported by registration stage data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase 2 study investigating sintilimab in combination with fruquintinib in endometrial cancer patients who have experienced disease recurrence, disease progression or intolerable toxicity with treatment on platinum-based doublet chemotherapy.
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