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FDA Rejects BeyondSpring’s NDA for Neutropenia Therapy

December 3, 2021

The FDA has sent a complete response letter to BeyondSpring Pharmaceuticals denying approval of the company’s new drug application (NDA) for plinabulin in combination with granulocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia (CIN), an abnormally low white blood cell count.

The agency indicated that the results of the single trial BeyondSpring conducted were not sufficiently robust to demonstrate benefit, and that a second well-controlled trial would be required to support the CIN indication, the company said.

BeyondSpring said it remains confident in the efficacy and safety data for plinabulin and that it will work closely with the FDA to consider the possible future clinical pathway for the CIN indication.

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