BYSI - BeyondSpring fails to win FDA approval for plinabulin combo in neutropenia

BeyondSpring Pharmaceuticals (NASDAQ:BYSI) announced that the FDA has issued a Complete Response Letter (CRL) for its New Drug Application (NDA) seeking the approval of a combination regimen containing plinabulin for chemotherapy-induced neutropenia (CIN). The company had sought regulatory approval for plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for CIN, a common toxicity caused by anticancer drugs. Noting that a single trial was insufficient to support its licensure, the regulator has mentioned in the CRL the requirement for a second well-controlled trial to consider approval of the drug. “The Company plans to request a meeting with the FDA and remains committed to its goal of bringing plinabulin to cancer patients in need globally,” CEO of BeyondSpring (BYSI) Lan Huang remarked.

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BeyondSpring fails to win FDA approval for plinabulin combo in neutropenia