FDA issues a Complete Response Letter for plinabulin for prevention of chemotherapy-induced neutropenia.-BeyondSpring

The FDA issued the CRL to indicate that they have completed their review of the application and have determined that it cannot be approved in its present form. The FDA’s CRL indicated that the results of the single registrational trial (106 Phase III) was not sufficiently robust to demonstrate benefit and that a second well controlled trial would be required to satisfy the substantial evidence requirement to support the CIN indication.

The Company expects to work closely with the FDA to consider the possible future clinical pathway for CIN, which may include a second study. Plinabulin is the first drug candidate submitted for FDA approval that has the potential to work in the critical first week of chemotherapy treatment before G-CSF is effective, to prevent the onset and improve clinical outcomes of CIN.