The NMPA Accepts HUTCHMED and Innovent’s NDA for Fruquintinib Plus Sintilimab with Priority Review to Treat Endometrial Cancer


The NMPA has accepted & granted priority review to the NDA of fruquintinib + sintilimab for treating advanced endometrial cancer patients having pMMR1 or non-MSI-H2 tumors, were failed on previous systemic therapy & are not eligible for curative surgery or radiation
The NDA was based on the endometrial cancer registration arm, FRUSICA-1, of P-II study assessing fruquintinib + sintilimab to treat endometrial cancer patients having disease recurrence & progression or intolerable toxicity due to Pt-based doublet CT with the 1EP as ORR & the 2EPs as DCR, DoR, PFS, OS & PK characteristics
Additionally, in Jul 2023, the NMPA granted BTD to fruquintinib combined with sintilimab for the same indication


Related News:- HUTCHMED Receives the Pharmacy and Poisons Board of Hong Kong’s Approval for Elunate (fruquintinib) to Treat Metastatic Colorectal Cancer (CRC)

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