03.12.2024 11:53:56
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HUTCHMED Announces Approval For Fruquintinib Combination Therapy In China - Quick Facts
(RTTNews) - HUTCHMED China and Innovent Biologics, Inc. jointly announced that the New Drug Application for the combination of ELUNATE or fruquintinib, and TYVYT or sintilimab injection, has been granted conditional approval in China for the treatment of patients with advanced endometrial cancer with Mismatch Repair proficient tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation. 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 II study.
The companies noted that this marks the first regulatory approval for the combination of fruquintinib with a leading immune checkpoint inhibitor.
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