Takeda and HUTCHMED Report EMA’s Validation of MAA for Fruquintinib to Treat Metastatic Colorectal Cancer
Shots:
- The EMA has validated and accepted the MAA for regulatory review of fruquintinib, a highly selective and potent inhibitor of VEGFR -1, -2, and -3 for the treatment of adult patients with previously treated metastatic CRC
- The MAA was based on the results from the P-III trial (FRESCO-2) evaluating fruquintinib + BSC vs PBO + BSC in patients with previously treated metastatic CRC. The study was conducted in the US, EU, Japan & Australia along with data from the P-III trial (FRESCO)
- The (FRESCO-2) trial met its 1EPs & 2EPs which showed a significant and clinical improvement in OS and PFS, was well tolerated. The company is expected to submit an NDA to PMDA in 2023
Ref: Businesswire | Image: Takeda
Related News:- HUTCHMED Receives the NMPA’s Breakthrough Therapy Designation for Fruquintinib + Sintilimab to Treat Advanced Endometrial Cancer
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