HUTCHMED and Innovent Report the NMPA’s Conditional Approval of Elunate Plus Tyvyt to Treat Advanced Endometrial Cancer
Shots:
- The NMPA has granted conditional approval to the combination of Elunate (fruquintinib) and Tyvyt (sintilimab injection) to treat advanced endometrial cancer with pMMR tumors in patients, failed on prior systemic therapy and not eligible for curative surgery or radiation
- Approval was based on data from P-II (FRUSICA-1) trial of fruquintinib + sintilimab in advanced endometrial cancer. Results showed an ORR of 35.6%, DCR of 88.5%, mPFS of 9.5mos. & OS of 21.3mos., with median TTR of 1.6mos. Safety was consistent with similar therapies
- A confirmatory P-III study assessing the efficacy & safety of the combination vs CT in this population has been planned
Ref: HUTCHMED | Image: HUTCHMED & Innovent
Related News:- The NMPA Accepts HUTCHMED and Innovent’s NDA for Fruquintinib Plus Sintilimab with Priority Review to Treat Endometrial Cancer
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
