FN - FDA grants accelerated review to BeyondSpring's plinabulin combo application; shares up 8%

Under priority review, the FDA has accepted for filing BeyondSpring's (BYSI) 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)). The Agency has set PDUFA target action date for November 30, 2021.Priority Review designation accelerates the review time from 10 months to six from the date of acceptance of the filing. This NDA submission included data from PROTECTIVE-2 Phase 3 study in addition to five supportive trials of over 1200 patients.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.BYSI shares up 8% premarket trading at $11.18.

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FDA grants accelerated review to BeyondSpring's plinabulin combo application; shares up 8%