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.
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