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 patient population included in CIN prevention. If approved, plinabulin and G-CSF combination would be an important new and improved option to prevent CIN for approximately 467,500 cancer patients in the U.S. annually.”
This NDA submission included pivotal study PROTECTIVE-2 Phase 3 data in addition to five supportive trials of over 1200 patients. PROTECTIVE-2 Phase 3 registration study is a randomized, double-blind, controlled global trial, which showed that plinabulin in combination with pegfilgrastim demonstrated superior CIN prevention benefit, compared to pegfilgrastim alone. The study met the primary endpoint, in the rate of prevention of grade 4 neutropenia in Cycle 1 (improved from 13.6% to 31.5%, p=0.0015) and met all key secondary endpoints, including duration of severe neutropenia (DSN) and absolute neutrophil count (ANC) nadir. In addition, the combination reduced clinical complications such as incidence and severity of febrile neutropenia (FN) and incidence and duration of hospitalization for FN patients. The combination is well tolerated, with an over 20% reduction of Grade 4 Treatment-Emergent Adverse Events (TEAEs), including bone pain reduction, and importantly, a Quality of Life (QoL) benefit compared to pegfilgrastim alone.
About CIN
CIN remains a severely unmet medical need and is the primary cause for the 4D’s (Decrease, Delay, Discontinue dose and Downgrade regimen) that compromise carefully selected cancer treatment regimens. Treatment or prevention of CIN with G-CSF has been the standard of care since Neupogen® was approved in 1991. The main benefit o...
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