Hutchmed announced that it has initiated the filing of a rolling submission of a new drug application, or NDA, to the FDA for fruquintinib, a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3, for the treatment of refractory metastatic colorectal cancer, or CRC. HUTCHMED plans to complete the NDA submission in the first half of 2023, to be followed by filing of a marketing authorization application, or MAA, to the European Medicines Agency or EMA, and an NDA to the Japan Pharmaceuticals and Medical Devices Agency, or PMDA.
Published first on TheFly
See Insiders’ Hot Stocks on TipRanks >>
Read More on HCM:
- HUTCHMED Initiates Rolling Submission of NDA to U.S. FDA for Fruquintinib for the Treatment of Refractory Colorectal Cancer
- HUTCHMED Announces Strategy to Focus on Late-Stage Pipeline Regulatory Approvals
- HUTCHMED Rises on Positive Results in Gastric Cancer Trial
- HUTCHMED Announces Positive Topline Result in Fruquintinib Phase III FRUTIGA Study in Second-Line Gastric Cancer in China
