BeyondSpring : FDA Accepts NDA Of Plinabulin/G-CSF For Chemotherapy-Induced Neutropenia Prevention

(RTTNews) - BeyondSpring Inc. (BYSI) said that the U.S. Food and Drug Administration has accepted for filing, and with Priority Review, the company's New Drug Application or NDA seeking approval for use of plinabulin in combination with granulocyte colony-stimulating factor or G-CSF for the prevention of chemotherapy-induced neutropenia or CIN.

Plinabulin, a novel, intravenous infused small molecule, acts as a selective immunomodulating microtubule-binding agent (SIMBA), with immune anti-cancer activities, and broad activities in prevention of CIN across chemotherapy and cancer types.

The FDA has a Prescription Drug User Fee Act (PDUFA) target action date set for the plinabulin NDA of November 30, 2021.

The U.S. FDA and China NMPA previously granted Breakthrough Therapy Designation in September 2020 for plinabulin and G-CSF combination for "concurrent administration with myelosuppressive chemotherapeutic regimens in patients with non-myeloid malignancies for the prevention of CIN."