Posted by Michael Wonder on 02 Dec 2021
BeyondSpring Pharmaceuticals receives complete response letter from the FDA for plinabulin new drug application for prevention of chemotherapy-induced neutropenia
1 December 2021 - BeyondSpring Pharmaceuticals today announced it has received a complete response letter from the U.S. FDA for the new drug application seeking approval of plinabulin in combination with granulocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia.
The letter indicated that the results of the single registrational trial (106 Phase 3) 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 proposed indication.
