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BeyondSpring Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Plinabulin and G-CSF Combination for the Prevention of Chemotherapy-Induced Neutropenia (CIN)
- The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date for November 30, 2021 - Plinabulin and G-CSF combination has the potential to
About this update from Beyondspring, Inc.
[{"type":"text","content":"- The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date for November 30, 2021 - Plinabulin and G-CSF combination has the potential to raise the standard of care in CIN prevention for the first time in 30 years NEW YORK, June 01, 2021 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing, and with Priority Review, the Company's New Drug Application (NDA) seeking approval for use of plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (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. Priority Review is granted by the FDA to applications for medicines that, if approved, would provide significant improvements in the effectiveness or safety of the treatment, diagnosis, or prevention of serious conditions when compared to standard of care. In general, the FDA’s Priority Review designation accelerates the review time from 10 months to a goal of six months from the date of acceptance of the filing. 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.” \"We are pleased that the FDA has accepted with priority review our NDA filing for plinabulin, which is one of the key milestones for this product in 2021. We look forward to continue to work closely with the FDA through the review process,\" said Dr. Lan Huang, co-founder, CEO and chairwoman of BeyondSpring. \"Chemotherapy is a very important therapy regimen for cancer patients, even more so with its approval in combination with checkpoint inhibitors. With COVID-19, the NCCN panel had updated the guidelines to potentially double the p...