Chinese biopharma Hutchmed (HKEX:13) today announced that the New Drug Application (NDA) for tazemetostat for the treatment of adult patients with relapsed or refractory (R/R ) follicular lymphoma (FL) has been accepted for review and granted Priority Review by the China National Medical Products Administration (NMPA).
Tazemetostat is a first-in-class methyltransferase inhibitor of EZH2 developed by Epizyme, a subsidiary of French drugmaker Ipsen (Euronext: IPN).
Tazemetostat is approved by the US Food and Drug Administration (FDA) for the treatment of certain patients with R/R FL and certain patients with advanced epithelioid sarcoma (ES) under the FDA accelerated approval program.
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